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Nick Paul Taylor

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1869 articles by Nick Paul Taylor

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FDA posts guidance on how to simplify updates to antimicrobial resistance tests
Sept. 29, 2023
Abbott data suggests GLP-1 drugs a ‘modest accelerator’ for CGMs: analysts
Sept. 29, 2023
Artificial heart maker’s cash runway shrinks to 1 month after supply woes hurt sales
Sept. 28, 2023
Harbinger Health raises $140M to study blood-based cancer screening test
Sept. 28, 2023
Siemens Healthineers buys Aspekt to bolster radiation oncology services
Sept. 27, 2023
FDA finalizes guidance on cybersecurity for medical devices
Sept. 27, 2023
Clinical data from Boston Scientific and rivals could reshape pulmonary embolism market: analysts
Sept. 26, 2023
Enovis inks $847M acquisition to boost orthopedic reconstruction business
Sept. 26, 2023
Medtronic receives CE mark for CGM sensor, boosting challenge to Abbott and Dexcom
Sept. 25, 2023
FDA shares draft medical device harmonization plan to meet MDUFA V goal
Sept. 25, 2023
Hologic allies with Bayer to support uptake of contrast-enhanced mammography
Sept. 22, 2023
Is bigger better? McKinsey predicts the return of large medtech mergers
Sept. 22, 2023
Boston Scientific expects ‘dramatic shift’ to pulsed field ablation to fuel fast growth through 2026
Sept. 22, 2023
Limited resources constrain federal oversight of medical device ads, GAO finds
Sept. 21, 2023
Stryker adds minimally invasive bunion device to fast-growing extremities portfolio
Sept. 21, 2023
CMS leader defends breakthrough device reimbursement proposal at House hearing
Sept. 20, 2023
FDA makes device conformity testing scheme permanent to streamline assessments
Sept. 20, 2023
J&J starts trial of pulsed field ablation catheter with mapping feedback
Sept. 19, 2023
FDA releases draft guidance for studying weight loss devices
Sept. 19, 2023
FDA finalizes breakthrough device changes to target health inequities
Sept. 18, 2023
Beacon Biosignals receives FDA clearance for sleep tracking headband
Sept. 18, 2023
GE HealthCare partners with Mayo Clinic to accelerate work on imaging and AI
Sept. 15, 2023
Abbott’s neurostimulator recall, with 73 injuries reported, deemed Class I by FDA
Sept. 14, 2023
FDA finalizes biocompatibility guidance for devices that touch the skin
Sept. 14, 2023
FDA finalizes combination product guidance 7 years after sharing draft
Sept. 13, 2023
TB deaths prompt FDA warning on reducing transmission risk
Sept. 13, 2023
CMS digs deeper into impact of proposed breakthrough device pathway in JAMA paper
Sept. 12, 2023
Bausch + Lomb seeks funding for $1.75B eye drop acquisition from Novartis
Sept. 12, 2023
Sterigenics’ $408M ethylene oxide settlement removes ‘most problematic’ lawsuits: analysts
Sept. 8, 2023
Bayer faces Essure lawsuit after UK court clears 200 women to claim for damages
Sept. 8, 2023
Microsoft, Paige team to use supercomputers to train cancer pathology AI models
Sept. 8, 2023
FDA proposes 3 guidances to improve 510(k) clearance process
Sept. 7, 2023
Boston Scientific gets FDA nod for latest device in fast-growing Watchman franchise
Sept. 7, 2023
Cue Health board pressured by investor to review strategy, cut costs
Sept. 6, 2023
Guardant abandons cancer blood test trial early, restates confidence in product line
Sept. 6, 2023
23andMe wins FDA clearance to test for expanded set of BRCA cancer risk variants
Sept. 5, 2023
Medtronic sued for allegedly sharing ‘treasure trove’ of diabetes patient data with Google
Sept. 5, 2023
Spine volumes to grow 6.5% next year as post-pandemic boost continues: analysts
Sept. 1, 2023
Beta Bionics raises $100M to challenge Medtronic, Tandem for automated insulin dosing market
Sept. 1, 2023
UK regulators name 3 approved bodies to ease device certification bottleneck
Aug. 31, 2023
Hamilton Medical’s urgent ventilator notice deemed Class I recall by FDA
Aug. 31, 2023
Trade groups urge CMS to expand, quickly finalize breakthrough device pathway
Aug. 30, 2023
Withings wins FDA clearance for scale with AFib detection
Aug. 30, 2023
GE HealthCare rolls out software to speed assessment of AFib patients
Aug. 29, 2023
3M reaches $6B settlement to resolve combat earplug lawsuits
Aug. 29, 2023
Boston Scientific’s pulsed field ablation device matches standard of care in AFib trial
Aug. 28, 2023
US signs consent decree requiring EPA to finalize ethylene oxide rule by March
Aug. 28, 2023
VC funding in medtech ticks up, raising hopes that slump has bottomed
Aug. 25, 2023
Medtronic’s endovascular artificial intelligence pilot program treats first patient
Aug. 25, 2023
Draeger’s ventilator sound insulation recall triggers FDA Class I notification
Aug. 24, 2023
BARDA backs Satio’s work on patch-based Ebola test for use in remote settings
Aug. 23, 2023
Bayer inks deal to commercialize Mahana’s prescription digital therapeutics
Aug. 23, 2023
Levita’s surgeon-controlled arm for magnetic procedures gains 510(k) clearance
Aug. 23, 2023
23andMe rival warns consumer test approach misses 90% of cancer variants
Aug. 17, 2023
Edwards software linked to improved blood pressure control during surgery
Aug. 17, 2023
GE HealthCare wins FDA clearance for wireless hospital vital sign monitor
Aug. 16, 2023
Medtronic’s dialysis device recall assigned to Class I by the FDA
Aug. 16, 2023
Medtronic’s bid to dismiss heart device kickback claims fails, clearing case to advance
Aug. 15, 2023
Boston Scientific’s pivotal pulsed field ablation trial expected to succeed: analysts
Aug. 14, 2023
Cue Health wins $28M BARDA contract to develop rapid respiratory infection test
Aug. 14, 2023
Median lag between FDA authorization and Medicare coverage hits 6 years: study
Aug. 11, 2023
Getinge’s heart assist pump shutdown problem given FDA Class I recall tag
Aug. 11, 2023
ZimVie wins FDA approval for smaller Mobi-C cervical disc
Aug. 10, 2023
Device volumes to hold up against threat of Wegovy, other GLP-1 drugs: analysts
Aug. 9, 2023
Elon Musk’s brain implant company raises $280M to fund clinical trials
Aug. 9, 2023
Abbott lands FDA clearance of Alinity complete blood count system
Aug. 8, 2023
Appeals court overturns ruling in Axonics-Medtronic neurostim patent dispute
Aug. 8, 2023
Medtronic expected to prevail at FDA renal denervation vote despite data doubts: analysts
Aug. 7, 2023
Anne-Françoise Nesmes to step down as Smith+Nephew CFO next year
Aug. 7, 2023
Penumbra says stroke device delayed at least 12 months due to FDA request
Aug. 4, 2023
Outset pauses shipments of dialysis accessory after FDA warning letter, denting sales outlook
Aug. 4, 2023
CMS inpatient final rule will have muted impact on medtech companies, analysts say
Aug. 3, 2023
AI reduces radiologist workload in mammography clinical trial but expert urges caution
Aug. 2, 2023
Cooper scraps $875M takeover of Cook Medical business after FTC investigation
Aug. 2, 2023
Varian logistics slow growth at Siemens Healthineers in Q3
Aug. 2, 2023
Abbott pulls Trifecta heart valves from US market over deterioration rate
Aug. 1, 2023
Integra warns impact of plant closure will continue into 2024, with delays possible
July 31, 2023
GE HealthCare oxygen sensor recall gets Class I label from FDA
July 31, 2023
FDA shares draft guidance on studying medtech treatments for opioid use disorder
July 28, 2023
Dexcom hails CGM share gains as driver of 25% revenue growth in Q2
July 28, 2023
Abbott recall of heart catheter categorized as Class I event
July 27, 2023
Edwards’ TAVR results hurt by pandemic aftereffects and competition in Q2
July 27, 2023
Demand for 4-in-1 test helps Danaher’s COVID sales beat internal forecast
July 26, 2023
FDA adopts new sterilization standard to support switch from ethylene oxide
July 26, 2023
FDA improves 510(k) turnaround times, but PMA waits hit record high: analysis
July 24, 2023
Hearing aids fail to improve cognition in randomized trial, but subgroup analysis offers hope
July 18, 2023
Big Health buys Limbix to add adolescent depression app to digital therapeutic portfolio
July 18, 2023
FDA provides safety update on hernia repair mesh as medtech companies face lawsuits
July 17, 2023
AdvaMed says CMS radiotherapy rate cut proposal will limit patient access
July 17, 2023
Problem with Draeger transport ventilators categorized as Class I recall by FDA
July 14, 2023
Urotronic wins FDA approval to challenge Boston Scientific, Teleflex for prostate market
July 13, 2023
US trade body again delays decision on Apple-Masimo patent dispute
July 13, 2023
Analysis shows paclitaxel-coated devices unlikely to increase death risk, leading FDA to withdraw warning
July 12, 2023
J&J Megadyne unit’s electrode pad recall labeled Class I over burn risk
July 12, 2023
Analysts expect a reimbursement boost for Shockwave coronary artery-clearing device
July 11, 2023
Automated machine learning model identifies patients at risk for surgical complications
July 11, 2023
Coloplast to pay $1.2B upfront to buy fish skin wound care business Kerecis
July 10, 2023
Medtronic secures Medicare coverage for MiniMed 780G insulin pump
July 10, 2023
ResMed buys Somnoware to expand sleep management software portfolio
July 7, 2023
BD to shed 60 jobs as COVID demand, diabetes spinoff affect manufacturing plant
July 7, 2023
FTC intervenes to correct Medtronic’s ‘erroneous assertions’ in antitrust case
July 6, 2023
European guidelines offer support for renal denervation in hypertension, boosting Medtronic, ReCor
July 6, 2023
Startup’s fast-acting wound treatment gel gets FDA nod for use in humans
July 5, 2023
GPT-4 language model gives limited quality medical answers in study
July 5, 2023
Roche test for accelerating Alzheimer’s diagnosis granted FDA clearance
June 30, 2023
Diabetes remains fastest-growing medtech market despite some risk from new drugs: analysts
June 30, 2023
FDA seeks feedback on technologies that can enable healthcare at home
June 29, 2023
FDA repeats restrictions on NuVasive limb-lengthening device after clearing pediatric use
June 29, 2023
Teleflex recall of separating vascular catheters labeled Class I event
June 28, 2023
Invacare names Kai Zhu as CFO
June 28, 2023
Illumina plans layoffs, closure of San Diego facility in push to save $100M a year
June 27, 2023
Restor3d inks Conformis buyout, adding hip and knee implants to portfolio
June 27, 2023
Medtronic links 780G insulin pump to benefits in kids as it works to grow sales
June 26, 2023
Dexcom targets 25M Americans with new CGM aimed at non-insulin-using diabetics
June 26, 2023
Intuitive’s Ion platform may provide ‘most exciting advancements in robotic technology’: analysts
June 23, 2023
Sterigenics moves closer to end of ethylene oxide lawsuit as most claimants accept $408M deal
June 23, 2023
Bigfoot links smart insulin pen cap to improved glycemic control in real-world study
June 22, 2023
GE HealthCare partners with J&J to push spine imaging system
June 22, 2023
Owlet receives FDA clearance for prescription pulse oximetry baby sock
June 22, 2023
Surgalign files for bankruptcy, agrees to sell US hardware unit for $5M
June 21, 2023
Exact Sciences’ next-gen colorectal cancer test hits primary goals in pivotal study
June 21, 2023
Philips gets slapped with two legal challenges by French patients in ‘Respiratorgate’
June 21, 2023
Siemens Healthineers laying off 67 people as $327M diagnostic cost-cutting push begins
June 20, 2023
Analysts highlight Masimo’s advantages over Apple, Fitbit ahead of proxy vote
June 20, 2023
Wrist-worn wearable could detect sickle cell pain episodes
June 16, 2023
Wound repair, custom prosthetics targeted by developers of multi-material bioprinter
June 14, 2023
Samsung adds heart rhythm notifications to Galaxy Watch to close gap on Apple
June 14, 2023
Abbott’s $1.9B electrophysiology unit threatened by pulsed field ablation: analysts
June 13, 2023
Huma hails 510(k) clearance as boost to digital health product development
June 13, 2023
Illumina CEO Francis deSouza resigns weeks after surviving Icahn board battle
June 12, 2023
SunMed agrees to $110M takeover of Avanos’ respiratory health unit, continuing M&A spree
June 9, 2023
In shift away from toxic ethylene oxide, Colorado firm offers ‘green’ chlorine dioxide sterilization
June 8, 2023
Precision Neuroscience’s brain implant maps electrical activity in a first-in-human trial
June 8, 2023
Low-cost, disposable ‘pencil-on-paper’ sensor opens population health opportunities
June 7, 2023
FDA: iRhythm targeted heart monitor at ‘high-risk’ patients without seeking clearance
June 7, 2023
Cue Health’s inability to find post-COVID markets for testing prompts Goldman downgrade
June 5, 2023
Masimo board accepts appointment of activist investor’s nominee, with caveats
June 5, 2023
Illumina trains AI on primate data to estimate risk of rare variants in humans
June 2, 2023
BD names Laura Boros president of pharmaceutical systems
June 2, 2023
Masimo pushes back against activist investor it argues will cause ‘dysfunction and chaos’
June 1, 2023
FDA hits iRhythm with warning letter over problems at heart monitor facility
June 1, 2023
MedTech Europe sets out position on cybersecurity, making case for reliance on MDR
May 31, 2023
Microrobots powered by ultrasound show progress in drug delivery experiments in mice
May 31, 2023
Titan licenses robotic surgery intellectual property to Intuitive after failing to find buyer
May 30, 2023
Illumina accused of ‘playing delay tactics’ to push back EU decision on divesting Grail: Financial Times
May 30, 2023
Boston Scientific cancels $230M stent deal after regulators erect barriers to acquisition
May 26, 2023
Abbott’s remote heart failure monitoring system reduces hospitalizations in clinical trial
May 26, 2023
Slump in medtech VC activity continues as inflation keeps investors on the sidelines
May 25, 2023
Acurable prepares to challenge ResMed for sleep apnea diagnosis market
May 25, 2023
FDA teams with Veterans Health Administration to make medtech supply chains more resilient
May 24, 2023
Integra recalls all devices made at Boston facility in the past 5 years, pauses production
May 24, 2023
Orthopedic markets to return to normal this year as post-pandemic boost fades: analysts
May 23, 2023
PulseAI algorithm beats Apple Watch software at detecting atrial arrhythmias
May 23, 2023
Beta Bionics wins FDA nod to challenge Medtronic for automated insulin pump market
May 22, 2023
Thermo Fisher gets FDA clearance for first blood test of severe preeclampsia risk
May 22, 2023
Abbott, Boston Scientific, Medtronic share data on heart rhythm devices at conference
May 22, 2023
Abbott gains edge over cardiac monitor rivals with FDA clearance of 6-year device
May 19, 2023
Chinese medtechs post data on renal denervation devices to rival Medtronic, ReCor
May 19, 2023
J&J names Jasmina Brooks as president of Biosense Webster
May 18, 2023
Clinical trials showcase potential roles for ultrasound in treating cancer, inflammatory disease
May 18, 2023
Abbott wins FDA spinal cord stimulation approval to challenge Nevro for back pain market
May 17, 2023
Cook Medical lays off 500 after ‘significant change’ to operating environment
May 16, 2023
Diabetes app developers must generate more data on clinical effectiveness, study says
May 16, 2023
Embecta joins Tidepool to develop insulin pump, raises Q2 growth outlook
May 15, 2023
GE HealthCare’s order book raises questions about sales-growth potential, analysts say
May 12, 2023
AdvaMed cites EPA’s own impact assessment to push back against ethylene oxide proposals
May 12, 2023
Google adds image analysis capabilities to generative AI model, enabling dialogues with doctors
May 11, 2023
NuVasive grows sales in Q1, allaying concerns about impact of $3.1B Globus merger
May 11, 2023
Philips loses vote as shareholders push back against handling of respirator recall
May 10, 2023
Baxter, GE HealthCare, Philips are at risk from changes in hospital spending: Moody’s
May 9, 2023
FDA calls for ‘nimble’ regulation of ChatGPT-like models to avoid being ‘swept up quickly’ by tech
May 9, 2023
iRhythm says it received DOJ subpoena regarding company’s ‘products and services’
May 5, 2023
Algorithm may help avoid 40% of kidney transplant rejection misdiagnoses: study
May 5, 2023
FDA posts draft guidance on studying medical devices in decentralized clinical trials
May 4, 2023
Tandem expects to meet ‘key’ goals even as rival’s device launch may curb short-term sales growth
May 4, 2023
Dexcom proposes $1.1B debt offering to add to existing $2.6B cash reserve
May 3, 2023
Analyst ‘blown away’ by robot-fueled growth of Stryker’s hip and knee sales
May 2, 2023
Hologic, after overcoming chip shortage, starts considering larger M&A deals
May 2, 2023
Great Britain proposes allowing CE marks until 2030 to minimize Brexit disruption
May 1, 2023
Amazon closes Halo health tracking unit as wave of tech layoffs continues
May 1, 2023
Dexcom reports ‘growing momentum’ behind G7 launch in first quarter
April 28, 2023
ResMed device sales jump 43% as supply constraints ease
April 28, 2023
Edwards Q1 revenue boosted by growth at TAVR unit, surgical structural heart business
April 27, 2023
Illumina, under pressure from Icahn, outlines plan to reduce more expenses
April 26, 2023
Know Labs hopes to advance non-invasive glucose sensor with proof-of-concept test
April 25, 2023
Graphene ‘tattoo’ pacemaker senses and treats irregular heart beats in rats
April 24, 2023
Medtronic wins FDA approval for long-delayed MiniMed 780G insulin pump
April 24, 2023
Report names connected medical devices with the biggest cybersecurity risks
April 21, 2023
Abbott hit with FDA warning letter over unapproved changes to heart disease test
April 20, 2023
Fresenius flags fault with infusion system acquired last year in $240M deal
April 20, 2023
AFib study shows no effect on outcomes from 1-year delay of catheter ablation
April 19, 2023
Intuitive posted 26% jump in robotic procedures in Q1 as hospitals chipped away at backlog
April 19, 2023
Post-approval modification of high-risk devices linked to 30% jump in recall risk: study
April 18, 2023
Proxy adviser backs diabetes device developer Sernova in fight against activist investors
April 17, 2023
Medtronic targets June closure of Epix facility, will lay off 59 employees
April 14, 2023
Digital surgery firm Surgalign faces delisting by Nasdaq for shareholder equity noncompliance
April 14, 2023
OTC hearing aid matches performance of audiologist-fitted device in small trial
April 13, 2023
Medtech sector poised for growth as healthcare staffing tops pre-COVID levels: KeyBanc
April 13, 2023
Function Oncology raises $28M to use CRISPR to tailor cancer diagnosis and treatment
April 12, 2023
FDA starts device sterilization pilot program to help industry adapt to EtO emission clampdown
April 12, 2023
GE HealthCare faces ‘competition from all angles’ that could constrain growth: analysts
April 11, 2023
Medtech buyouts by private equity in Q4 shed light on deal-making trends in 2023: report
April 11, 2023
Philips recalls 1,200 reworked sleep apnea devices over fault that can cause therapy failure
April 10, 2023
Sernova defends record after investors attack ‘sluggish’ progress of regenerative medicine implant
April 7, 2023
Medtech servicing timelines and costs improve as technician turnover creates skills challenge
April 6, 2023
Medtronic’s Hugo too similar to Intuitive’s surgical robot to displace the market incumbent: analysts
April 5, 2023
Masimo receives De Novo nod from FDA for device designed to detect signs of opioid overdose
April 4, 2023
Getinge’s quality woes continue: FDA categorizes another heart pump recall as Class I event
April 3, 2023
Safety of fixed palatal expanders probed by FDA amid patient lawsuits
March 31, 2023
FDA qualifies tool for predicting temperature rise when orthopedic implants enter MRI scanners
March 31, 2023
ICU Medical challenges GE HealthCare for Medtronic units valued at $8B: report
March 30, 2023
Potential to improve early cancer detection lands Elypta prize inspired by Star Trek creator
March 30, 2023
In a threat to diabetes tech market, scientists use implanted glucose-run fuel cell to power insulin release
March 29, 2023
Getinge heart pump has CE mark suspended by second notified body, halting sales for 3 months
March 28, 2023
AntennaWare secures patent for wireless tech designed to unlock implant applications
March 27, 2023
Intuitive’s ecosystem means it will take J&J, Medtronic years to win surgical robot market share: analysts
March 24, 2023
Exactech implants may oxidize, FDA says, warning surgeons not to use any recalled joints
March 24, 2023
Medtronic merges robotic, legacy surgery businesses into one unit
March 23, 2023
SonderMind acquires technology from Mindstrong ahead of digital health startup’s shutdown
March 23, 2023
NuVasive shareholders expected to ‘begrudgingly’ back Globus’ $3.1B takeover amid lack of other bidders
March 22, 2023
Boston Scientific, Medtronic expected to quickly capture new atrial fibrillation market: analysts
March 21, 2023
Olympus accused of ‘troubling disregard for patient safety’ by FDA after flurry of warning letters
March 20, 2023
FDA sets end date for raft of COVID-related shortages that began early in pandemic
March 20, 2023
Trade group warns FDA human factors proposal is ‘too expansive,’ will strain agency resources
March 17, 2023
Senseonics grows sales in Q4 despite ‘softer demand’ for CGM implant in US and Germany
March 17, 2023
Tandem, targeting Medtronic and Insulet’s turf, links artificial pancreas to improved outcomes in kids
March 16, 2023
Medtech trade group pushes UK to support ambitious Software as a Medical Device program
March 15, 2023
Joint replacement business likely to be busy for the next year or more: BTIG analysts
March 14, 2023
Ex-medtech CEO arrested over alleged scheme to sell dummy devices, defraud Medicare
March 10, 2023
J&J lays off 350 people at robotics units, says ‘we have to get better’ with Ottava
March 9, 2023
QuidelOrtho COVID test is first to win FDA nod via premarket review
March 9, 2023
iRhythm, fighting Boston Scientific for market share, shows cardiac monitor beats rivals
March 8, 2023
Sooma’s neuromodulation therapy for depression granted FDA breakthrough status
March 8, 2023
Medtronic TAVR data in healthier patients fuels battle with Edwards for heart valve market share
March 7, 2023
Medtechs plan to centralize regulatory information management in modernization push: survey
March 7, 2023
Abbott’s TriClip improves tricuspid regurgitation in pivotal trial ahead of showdown with Edwards
March 6, 2023
Phone app tracks cough frequency in tuberculosis trial, opening up monitoring opportunity
March 6, 2023
Elon Musk’s bid to study brain implant in humans rejected by FDA on safety grounds: report
March 3, 2023
FDA Class I recalls hit 15-year high in 2022
March 3, 2023
FDA moving ahead with rulemaking on lab developed tests without waiting for Congress: BioWorld
March 2, 2023
Remote patient monitoring increasingly popular, even as pandemic eases, analysis of insurance claims shows
March 2, 2023
Boston Scientific to lay off 120 people at ex-Preventice site, continuing run of medtech cuts
March 1, 2023
ReCor follows Medtronic in making case for renal denervation as FDA mulls approval decision
March 1, 2023
Abbott heart valve deteriorates faster than rival device, FDA says in notice
Feb. 28, 2023
GE HealthCare forms Chinese joint venture to sell non-premium imaging systems
Feb. 28, 2023
Olympus agrees to $370M gastrointestinal stent takeover as medtech M&A rebound continues
Feb. 28, 2023
Medtronic links MiniMed 780G automated insulin delivery to sustained glucose control benefits
Feb. 27, 2023
FDA authorizes first at-home flu-COVID-19 combination test days after its developer files for bankruptcy
Feb. 27, 2023
Insulet exceeds sales forecast amid signs Omnipod 5 is winning share in diabetes pump market
Feb. 24, 2023
Getinge has CE marks suspended on life support sets over sterile packaging issues
Feb. 24, 2023
TAVR placement gets optimized with use of pumping, 3D-printed hearts by MIT researchers
Feb. 24, 2023
Globus’ full-year sales top $1B as analysts continue to question wisdom of NuVasive takeover
Feb. 23, 2023
Smith+Nephew posted underlying sales growth in Q4; profit slides
Feb. 23, 2023
Philips executives waive bonuses after year of recalls; ex-CEO gets $222,000
Feb. 22, 2023
Spinal cord stimulation shows ability to improve motor function in stroke patients in small trial
Feb. 21, 2023
Henry Schein Q4 profit drops, hurt by falling sales of COVID test kits, PPE
Feb. 17, 2023
GE’s nuclear imaging device can crush patients, FDA says, as Class I recall issued
Feb. 17, 2023
AI devices need dedicated FDA regulatory pathway to reduce bias risk, say researchers
Feb. 16, 2023
Applied Medical suit against Medtronic alleges surgical-device bundling practice curbs competition
Feb. 16, 2023
Boston Scientific, MDMA call for more transparency and oversight of Medicare Advantage plans
Feb. 15, 2023
Alcon to pay J&J $199M to settle dispute over patents for laser eye surgery device
Feb. 14, 2023
Insulet pays Bigfoot Biomedical $25M for pump-based automated insulin delivery technology
Feb. 14, 2023
Medtronic ordered by jury to pay $106.5M to Colibri over TAVR patent infringement
Feb. 13, 2023
82 more deaths linked to Philips’ recalled devices reported to FDA, bringing total to 346
Feb. 10, 2023
Baxter to cut about 3,000 jobs after earnings slump on supply chain woes
Feb. 10, 2023
Medtech CDMO sector poised for M&A rebound in 2023 amid ‘attractive’ targets: report
Feb. 9, 2023
Illumina posts sales slump in Q4, bets on new sequencing machine to drive 2023 growth
Feb. 8, 2023
Onshoring, easing labor market expected to drive double-digit growth at US medtech CDMOs
Feb. 8, 2023
Diagnostic firms turn to restructuring in bid to preserve cash: Goldman
Feb. 7, 2023
Bayer partners with Huma to create online tool for assessing cardiovascular risk factors
Feb. 7, 2023
Medtech earnings highlights: Easing of macro pressures, accelerated growth in 2023
Feb. 6, 2023
Sensor-loaded, $1 smart glove being tested to reduce stillbirths, maternal deaths
Feb. 6, 2023
Quest cuts 2023 COVID tests forecast amid continued slump in demand; Q4 profit plunges
Feb. 3, 2023
Siemens Healthineers forecasts revenue growth to accelerate despite supply chain woes
Feb. 2, 2023
Vortex ultrasound accelerates brain blood clot clearance in early stage tests
Feb. 2, 2023
FDA device center’s 2022 report reveals 37% drop in annual breakthrough designations
Jan. 31, 2023
Philips will cut 6,000 more jobs to reduce costs after company swung to net loss in Q4
Jan. 30, 2023
Medtronic wearable partner files for bankruptcy but plans to continue ‘without interruption’
Jan. 27, 2023
Researchers create remote-controlled biological robot that could eventually be used in surgery
Jan. 26, 2023
Getinge heart pump gets third Class I recall after patient death
Jan. 26, 2023
Intuitive Q4 profit slips on costs to boost share of robotic surgery market
Jan. 25, 2023
3M’s healthcare unit Q4 earnings drop on nurse shortages, falling hospital budgets
Jan. 25, 2023
Insulet reports personal-data leak of 29,000 insulin pump customers
Jan. 24, 2023
Ethylene oxide regulation may disrupt device supply, AdvaMed warns White House
Jan. 23, 2023
Stanford team reports progress with Theranos-like finger prick blood test
Jan. 23, 2023
FDA demands additional data on Abbott rival to Medtronic balloon, setting back approval timeline
Jan. 20, 2023
CT scans offer new path to diagnose treatable cause of high blood pressure, study shows
Jan. 19, 2023
Medtech hazards: Problems with Philips’ recall put safety of home-use devices at top of danger list
Jan. 19, 2023
Deep learning may improve triaging of people with acute chest pain, study shows
Jan. 19, 2023
Abbott’s FDA approval for TAVI device tees up challenge to Edwards, Medtronic: analysts
Jan. 18, 2023
Shockwave to pay $100M for Neovasc, adding refractory angina treatment to device pipeline
Jan. 18, 2023
AI predicts lung cancer risk six years into the future using single CT scan: study
Jan. 17, 2023
iRhythm shows signs of progress even as it ‘still has a way to go’ on key challenges: William Blair
Jan. 13, 2023
Akili cuts 30% of staff to focus cash on growing prescription video game sales
Jan. 13, 2023
‘Mixed signals’ from medtech management suggest industry had bumpy end to 2022: analysts
Jan. 13, 2023
Google sibling Verily to lay off about 200 workers as it focuses on precision risk business
Jan. 12, 2023
Apple Watch infringed on Masimo patent, judge rules, raising prospect of import ban
Jan. 12, 2023
Cue Health lays off 388 people as demand falls for COVID-19 tests
Jan. 11, 2023
Rethinking 510(k): Studies show risk of using recalled devices as predicates for FDA clearance
Jan. 11, 2023
Sterigenics reaches $408M ethylene oxide settlement to resolve hundreds of lawsuits in Illinois
Jan. 11, 2023
Beta Bionics hires Harvard diabetes expert as CMO ahead of artificial pancreas launch
Jan. 10, 2023
Cardiac wearable maker iRhythm sees ‘nice progress’ in recovering from Q3 challenges
Jan. 10, 2023
Guardant Health posts revenue growth in Q4 on higher clinical testing volumes
Jan. 10, 2023
Dental medtech market remains steady amid ‘robust’ US employment: Henry Schein
Jan. 9, 2023
European Commission formalizes plan to extend MDR transition out to 2027, 2028
Jan. 9, 2023
Vivos bounces back from FDA rejection to land 510(k) clearance for sleep apnea treatment
Jan. 6, 2023
Labcorp hires ex-Quintiles CEO to lead clinical development unit ahead of upcoming spinoff
Jan. 6, 2023
AstraZeneca extends C2i pact to validate minimal residual disease solid tumor blood test
Jan. 6, 2023
Illumina signs new $750M credit agreement after bumpy year
Jan. 5, 2023
Roche receives first European IVDR certificate for companion diagnostic
Jan. 5, 2023
‘Mea culpa’: What Goldman Sachs analysts got wrong about Medtronic in 2022
Jan. 4, 2023
ReCor names Healthineers exec Barghout as CEO ahead of showdown with Medtronic
Jan. 4, 2023
Apple infringed on AliveCor wearable patents, ITC says in final ruling; import ban suspended
Jan. 4, 2023
Olympus agrees to $80M takeover of artificial intelligence endoscopy startup Odin Vision
Dec. 21, 2022
As diabetes technology advances, blood glucose control declines: study
Dec. 21, 2022
Fujifilm agrees to buy Inspirata’s Dynamyx in challenge to Philips for digital pathology market
Dec. 21, 2022
Medtronic starts US robotic surgery trial in push to challenge Intuitive
Dec. 20, 2022
Novo Nordisk expands Amalgam Rx insulin app pact, plots integration with other devices
Dec. 20, 2022
MDR costs are driving manufacturers to pull products from European market: report
Dec. 20, 2022
J&J subsidiaries accuse former Auris employees of stealing robotic surgery trade secrets
Dec. 19, 2022
Click wins FDA breakthrough designation for prescription digital migraine therapy
Dec. 19, 2022
Pivotal data on Guardant’s colorectal cancer blood test raise doubts about commercial prospects
Dec. 19, 2022
J&J leads $85M investment in HistoSonics ahead of liver cancer device authorization
Dec. 14, 2022
Tandem agrees to buy AMF, challenging Insulet for insulin pump patch market
Dec. 14, 2022
SD Biosensor postpones closing of $1.53B Meridian acquisition to complete financing
Dec. 14, 2022
Apple locked in court battles with small medtech firms over allegations of stolen technology
Dec. 13, 2022
Ypsomed seeks new partner for US insulin pump launch as Lilly quits deal
Dec. 12, 2022
EU Health Commissioner proposes MDR delay to prevent medical device shortages
Dec. 12, 2022
Investors hand Vaxxas $23M to support trial of needle-free COVID-19 vaccine
Dec. 12, 2022
Chinese market recovery could spur international medtech growth in 2023: Goldman
Dec. 9, 2022
Cochlear’s $120M purchase of hearing-implant maker stirs European scrutiny
Dec. 9, 2022
AdvaMed asks FDA to withdraw divisive draft guidance on LASIK surgery
Dec. 8, 2022
FDA outlines benefits and risks of emerging augmented and virtual reality medical devices
Dec. 8, 2022
Apple prevails in AliveCor patent dispute ahead of potential Watch import ban
Dec. 8, 2022
Stanford’s smart bandages accelerate wound healing in preclinical tests
Dec. 7, 2022
Ekso Bionics buys Indego lower limb exoskeleton business from Parker Hannifin for $10M
Dec. 7, 2022
Excess deaths to continue constraining recovery of TAVR market in 2023: Goldman
Dec. 7, 2022
Zimmer, Boston Scientific set to lead positive medical device pricing trend in 2023: analysts
Dec. 6, 2022
AI detects prediabetes in CGM data, opening up new use for device: study
Dec. 6, 2022
Reducing medtech waste: new PVC recycling process unlocks opportunity
Dec. 6, 2022
Getinge heart support devices join FDA shortage list as raw-materials supply slows production
Dec. 5, 2022
Vulnerability in BD’s infusion pump flagged to US cybersecurity agency
Dec. 5, 2022
Medtech procedure volume pressures ease on healthcare hiring: Goldman
Dec. 5, 2022
Integra to buy Surgical Innovation Associates for $50M in bid to lead growing breast reconstruction niche
Dec. 2, 2022
Eargo raises $32M to fight rivals in over-the-counter hearing aid market
Dec. 1, 2022
European biomedical group backs delaying MDR certification deadline amid ‘looming crisis’
Dec. 1, 2022
UroMems starts clinical trial of smart, automated implant to treat incontinence
Nov. 30, 2022
GE Healthcare, MediView XR partner to launch augmented reality X-ray imaging system
Nov. 30, 2022
Medtronic touts benefits of latest Evolut TAVR system in retrospective analysis
Nov. 30, 2022
World’s largest particle physics laboratory backs push to transform cancer radiotherapy
Nov. 29, 2022
Google Health licenses breast cancer detection AI to iCAD
Nov. 29, 2022
Baxter recall of connected incontinence pads ranked by FDA as Class I event
Nov. 28, 2022
Masimo’s pulse oximeter has no significant racial bias, study finds
Nov. 28, 2022
Europe faces 2024 bottleneck in device reapprovals as submissions slow
Nov. 28, 2022
‘Tripledemic’ concerns spur FDA to issue emergency authorization for flu-COVID-19 combination test
Nov. 23, 2022
ResMed closes $1B Medifox buyout to expand software business into Europe
Nov. 23, 2022
Zimmer lands 510(k) clearance for 3D-printed cementless knee replacement
Nov. 22, 2022
Apple earbuds show promise as hearing aids in clinical trial
Nov. 22, 2022
AI-powered blood test detects liver cancer, opening opportunity to improve screening
Nov. 22, 2022
Apple Watch app for monitoring Parkinson’s symptoms earns FDA clearance
Nov. 21, 2022
How wearable devices with skin-like stretchability may pave way for better health tracking
Nov. 21, 2022
AdvaMed pushes Biden to use $52B chip program to support medtech supply chains
Nov. 18, 2022
Philips’ ventilator woes grow as FDA issues alert over replacement foam
Nov. 18, 2022
AEYE Health wins FDA clearance for AI-powered eye test to expand diabetic screening
Nov. 18, 2022
Roche gets EUA for high-throughput monkeypox test
Nov. 17, 2022
Insulet warns Omnipod 5 insulin pump charge issue may cause fire
Nov. 17, 2022
Medtronic doubles wear time of insulin pump infusion sets
Nov. 16, 2022
Penumbra expands VR rehabilitation platform with lower body sensors
Nov. 16, 2022
NFL expands program to use sensor-loaded mouthguards to gather head impact data
Nov. 15, 2022
Illumina cuts workforce by 5% amid supply chain woes, sales slowdown
Nov. 15, 2022
ResMed, Google sibling Verily form digital health venture to improve access to sleep treatment
Nov. 15, 2022
Tandem pump, paired with Dexcom CGM, boosts blood glucose control in Type 2 diabetics
Nov. 14, 2022
Mayo Clinic creates product to test AI models for bias and inaccuracy
Nov. 14, 2022
Green light shows promise in addressing oximetry racial bias: study
Nov. 14, 2022
Roche starts OTC sales of COVID-19 test in first push into US market
Nov. 11, 2022
GE HealthCare prices offering of $8.25B in bonds as part of spinoff
Nov. 11, 2022
Medtech execs ‘rethink’ long-term strategies as care settings shift: Accenture report
Nov. 10, 2022
J&J names Tezel global head of medtech R&D as Shen retires
Nov. 10, 2022
Affordable alternative: Smartphone-based hearing test for infants targets developing countries
Nov. 9, 2022
Lilly’s new diabetes management platform to integrate Dexcom CGM
Nov. 9, 2022
Siemens Healthineers beats sales forecasts on imaging demand as diagnostic pressures prompt restructuring
Nov. 9, 2022
Verily’s Onduo cut blood sugar in retrospective study of Type 2 diabetics
Nov. 8, 2022
Power play: How harvesting energy from lungs may end need to replace batteries in brain stimulators
Nov. 8, 2022
Medtronic’s AFib ablation device beats antiarrhythmic drugs in 3-year study
Nov. 8, 2022
OTC hearing aid maker Nuheara gets 510(k) clearance for HP-branded device, undercuts Lexie, Sony on price
Nov. 1, 2022
Hologic quarterly sales beat forecast even as demand for COVID tests wanes
Nov. 1, 2022
Stryker sales growth limited by hospital staffing, ‘soft’ installations of Mako robot
Nov. 1, 2022
Brain surgery may get boost from new steerable catheter using minimally invasive robot
Oct. 31, 2022
Researchers develop light-based sensor to overcome diagnostic limitations of electrodes
Oct. 31, 2022
FDA breakthrough device designations fall in Q3 but record year still within reach
Oct. 31, 2022
Edwards says it expects sales to stall in Q4 as hospital staff shortages stymie TAVR growth
Oct. 28, 2022
ResMed quarterly profit rises on AirSense sales; CEO skeptical about timeline of Philips’ return to market
Oct. 28, 2022
Baxter warns hospitals to stop using connected incontinence pads over interference risk
Oct. 27, 2022
Thermo Fisher raises full-year revenue forecast after posting extra $200M in COVID-19 test sales in Q3
Oct. 27, 2022
Intuitive starts $1B accelerated stock repurchase, boosting recovery of share price
Oct. 27, 2022
3M healthcare sales growth curbed in Q3 by hospital staffing shortages ahead of unit spinoff
Oct. 26, 2022
BioIntelliSense buys AlertWatch, expanding Medtronic patient monitoring partnership
Oct. 25, 2022
Accelerate Diagnostics withdraws BD-partnered device after FDA demands 510(k) clearance
Oct. 25, 2022
Philips to cut 4,000 jobs amid net loss related to recalls, declining sales
Oct. 24, 2022
Boston Scientific, Edwards set to report Q3 results after ‘encouraging start’ to medtech earnings season
Oct. 24, 2022
Abiomed wraps up Impella post-approval studies requested by FDA
Oct. 21, 2022
Algorithm cuts disease biomarker analysis from hours to minutes in ‘leap forward’ for diagnosis
Oct. 21, 2022
FDA moves to make effect on health equity part of breakthrough device considerations
Oct. 21, 2022
GE forms pact with AMC Health to enable more remote monitoring in home care
Oct. 20, 2022
BD forms co-promotion pact with Magnolia to reduce blood culture contamination
Oct. 19, 2022
FDA seeks feedback on plans to draft and finalize medical device guidance in 2023
Oct. 19, 2022
Cordis to spend $235M to buy Swiss maker of alternative to paclitaxel balloons
Oct. 19, 2022
Lucid enters OTC hearing aid market, undercutting rivals with devices starting at $200
Oct. 18, 2022
Coloplast told by FDA to keep transvaginal mesh off market after 36-month surveillance study
Oct. 18, 2022
Medtronic, in a first, secures expanded label for cardiac pacing lead
Oct. 18, 2022
Avellino, Cepheid, GeneMatrix update COVID-19 test EUAs amid shift in FDA’s approach
Oct. 17, 2022
Johnson & Johnson, Alcon agree on $75M settlement to resolve contact-lens antitrust claims
Oct. 17, 2022
Abbott, J&J and Intuitive to lead off medtech earnings season; procedures, supply chain in spotlight
Oct. 17, 2022
Hospital staff shortages spurred drop in TAVR procedures in Q3, surgeon survey shows
Oct. 14, 2022
Bose-partnered Lexie to launch $999 OTC hearing aid, challenging Sony, Eargo in nascent market
Oct. 14, 2022
GE advances healthcare spinoff plan, providing close look at workings of the unit
Oct. 13, 2022
AI matches humans at detecting mental health red flags in text messages, study shows
Oct. 13, 2022
FDA starts advisory program pilot to reduce ‘valley of death’ risk for medical devices
Oct. 12, 2022
‘Do-it-yourself’ artificial pancreas system beats production-line pump in controlled trial
Oct. 12, 2022
FDA finalizes postapproval study guidance in light of AdvaMed, Foundation Medicine feedback
Oct. 11, 2022
Abbott’s FreeStyle Libre 2 CGM beats fingerstick testing in independent clinical trial
Oct. 11, 2022
Abbott lands FDA emergency authorization for first commercial monkeypox test
Oct. 10, 2022
NovaSight’s digital treatment for lazy eye gets FDA nod, providing alternative to patching
Oct. 10, 2022
Owlet seeks clearance of blood-oxygen-measuring baby sock after FDA warning letter
Oct. 10, 2022
‘Inadequate’ progress of Bayer’s study on birth-control implant called out by FDA as patients drop out
Oct. 7, 2022
Dexcom, Abbott have ‘massive opportunity’ with new CGM coverage proposal: analysts
Oct. 7, 2022
BD discloses cybersecurity vulnerability in cervical cytology processing machine
Oct. 6, 2022
Dexcom starts global rollout of G7 CGM system, launching device in U.K. and Germany
Oct. 6, 2022
Roche wins FDA approval for companion diagnostic to support breast cancer therapy
Oct. 5, 2022
Genentech, Winterlight track changes in Alzheimer’s using automated speech-based system
Oct. 5, 2022
Digital health funding collapsed in Q3, falling to lowest level since 2019: analysts
Oct. 5, 2022
Medical machine-learning studies lack high-quality clinical trials, review shows
Oct. 4, 2022
LivaNova recall of open-heart-surgery blood pump designated as Class I event by FDA
Oct. 4, 2022
Illumina ushers in $200 genome with the launch of new sequencers
Oct. 3, 2022
European AI Act could have ‘significant impact’ on manufacturers, medtech group warns
Oct. 3, 2022
Pulse oximeter bias delayed treatment of Black COVID-19 patients by hours: study
Sept. 30, 2022
Veterans Affairs, FDA partner to accelerate medical device development
Sept. 30, 2022
FDA finalizes guidance on how clinical decision support software is regulated
Sept. 28, 2022
FDA switches COVID-19 tests to De Novo, 510(k) pathways, limiting EUAs
Sept. 28, 2022
FDA makes case for ‘new regulatory paradigm’ amid hurdles in software-oversight program
Sept. 27, 2022
BD launches research-use monkeypox test, plans EUA filing for clinical use
Sept. 27, 2022
Puerto Rico-based lab ceases COVID-19 test; FDA revokes EUA
Sept. 26, 2022
Philips’ latest BiPAP machine recall labeled Class I event by FDA
Sept. 26, 2022
Forget oximeters, smartphone cameras detect 79% of cases of low blood oxygen in small study
Sept. 23, 2022
Medtronic gets first FDA approval for drug-eluting stent in bifurcation lesions
Sept. 22, 2022
Diabeloop’s insulin algorithm shows 17-point rise in time-in-range from year-long patient study
Sept. 22, 2022
Insulet’s Omnipod 5 gains CE Mark for European release
Sept. 21, 2022
Abbott’s FreeStyle Libre linked to 67% drop in hospitalizations for Type 2 diabetes patients: study
Sept. 21, 2022
Medtronic issues urgent notice about MiniMed insulin pump system vulnerability
Sept. 21, 2022
Jury decides against Sterigenics in ethylene oxide trial, awarding $363M to the sole plaintiff
Sept. 20, 2022
Hurricane Fiona unlikely to significantly disrupt medical device supply: analysts
Sept. 20, 2022
Medtronic starts full US commercial release of updated Evolut TAVR system
Sept. 19, 2022
Tasso’s at-home blood collection lancet wins FDA clearance
Sept. 15, 2022
Medtech firms increasingly positive about future as staffing, inflation pressures ease, say RBC analysts
Sept. 15, 2022
Edwards updates Sapien TAVR device for greater durability
Sept. 14, 2022
Sony partners with hearing aid specialist to enter new over-the-counter market
Sept. 14, 2022
Investor lawsuit accuses Medtronic of failing to disclose insulin pump problems
Sept. 13, 2022
Catheter Precision agrees to reverse merger, securing cash to target cardiac electrophysiology market
Sept. 13, 2022
Amid merger turmoil, Illumina’s Grail unit reports downturn in accuracy of blood-based cancer test
Sept. 12, 2022
Google sibling Verily raises $1B to invest in health data initiatives, replaces CEO
Sept. 12, 2022
FDA alerts physicians to lock malfunction with Abbott’s MitraClip heart valve device
Sept. 9, 2022
Cybersecurity firm finds vulnerabilities in Baxter’s Sigma infusion pumps
Sept. 8, 2022
Abbott heart device for newborns shows longer-term benefits with three-year data
Sept. 8, 2022
FDA clears Magnus neuromodulation system in major depressive disorder
Sept. 7, 2022
Philips recalls 17M sleep apnea masks over magnets that could affect implanted devices
Sept. 7, 2022
Federal jury convicts medtech executive in $77M blood testing kickback case
Sept. 6, 2022
Machine learning algorithm predicts unfavorable labor outcomes for mothers in retrospective study
Sept. 6, 2022
Vibrating, colon-stimulating capsule to treat chronic constipation approved by FDA
Sept. 2, 2022
Philips pays $24M to settle second set of claims by US Justice Dept.
Sept. 2, 2022
Baxter gets 510(k) clearance for syringe pump, spurring optimism of faster FDA review process
Sept. 1, 2022
Malfunctioning Integra intracranial monitor was used on patient who died: FDA
Sept. 1, 2022
Illumina opens first manufacturing facility in China to supply gene sequencing products
Aug. 31, 2022
Recall Watch: Hamilton ventilator, Intera pump recalls get Class I label from FDA
Aug. 30, 2022
Olympus to sell microscope unit for $3.1B as it bolsters focus on medical technology
Aug. 30, 2022
Penumbra’s catheters achieve first-pass revascularization in 68.9% of stroke patients
Aug. 26, 2022
Review finds ‘paucity of robust evidence’ on impact of AI clinical outcomes
Aug. 26, 2022
Medtronic gets CE mark for drug-eluting stent and kicks off European launch
Aug. 25, 2022
Abbott wins FDA approval for spinal cord stimulation treatment of multi-site pain
Aug. 24, 2022
Getinge’s recall of 11,000 ventilators labeled Class I event by FDA
Aug. 24, 2022
Lab group ACLA warns ‘inadequate’ payment rates may limit access to monkeypox testing
Aug. 23, 2022
Insulet’s Omnipod 5 insulin delivery system approved for preschool children
Aug. 23, 2022
Visibly wins FDA clearance for self-administered online vision test
Aug. 17, 2022
FDA reviews rise in Philips respiratory device reports, including 44 deaths
Aug. 17, 2022
Outset lands VA contract for portable hemodialysis system in ‘modest’ boost for sales
Aug. 16, 2022
Smartphone-linked blood pressure monitors fail to beat traditional devices, study finds
Aug. 16, 2022
BD’s recall of emergency vascular access devices labeled Class I event by FDA
Aug. 15, 2022
Abbott will invest $450M in Ireland to expand EU production of FreeStyle Libre CGMs
Aug. 15, 2022
Abbott blood test predicts death, unfavorable outcomes in traumatic brain injury patients, study finds
Aug. 12, 2022
Medtronic issues Class I recall of implantable cardioverter defibrillators in U.S.
Aug. 11, 2022
Roundup: Medical device industry confident it can ride out recession, wary of slowing capital sales
Aug. 10, 2022
Boston Scientific says it’s investigating allegations of anti-bribery law violations
Aug. 10, 2022
FDA’s hearing-aid guidance clears regulatory review amid push by lawmakers for OTC sales
Aug. 9, 2022
BD begins tender offers for up to $500M in debt to advance repayment strategy
Aug. 9, 2022
Senate passes $740B bill to lower healthcare costs after months of wrangling
Aug. 8, 2022
FDA’s breakthrough device designations poised for another record year
Aug. 8, 2022
QuidelOrtho reports 37.5% sales growth in first quarter since $6B merger
Aug. 5, 2022
SEC accuses surgical implant business of pulling forward sales to hit targets
Aug. 5, 2022
EPA names BD, Edwards and Medtronic on list of higher-risk sterilization facilities
Aug. 4, 2022
ResMed buys Mementor for prescription digital health app, continuing German expansion
Aug. 4, 2022
Virtual Incision opens new frontier for robotic surgery with space station mission
Aug. 3, 2022
Siemens Healthineers stumbles as lockdowns, falling COVID-19 sales and rising costs hit business
Aug. 3, 2022
Boston Scientific pays $85M to settle long-running patent dispute with Nevro
Aug. 2, 2022
FDA extends Class I UDI submission deadline, exempts consumer health devices from requirements
Aug. 1, 2022
FDA reauthorizes Meridian’s COVID-19 test after changes to enable omicron detection
Aug. 1, 2022
BD buys MedKeeper for $93M to continue expansion into pharmacy technology
July 29, 2022
Core diagnostic growth offsets falling COVID-19 sales at Hologic, Thermo Fisher, Qiagen
July 29, 2022
LASIK again under microscope as FDA seeks comment on improving patient communication
July 28, 2022
MedTech Europe pushes for semiconductor prioritization as US moves to increase local supply
July 27, 2022
Biotronik to pay $12.95M to settle kickback allegations of 'lavish' meals, abuse of training programs
July 26, 2022
Test makers urge House, Senate to include diagnostic reforms in user-fee bill
July 21, 2022
Smiths Medical's recall of syringe infusion pumps labeled Class I event after injuries, death
July 21, 2022
Defibrillators, chest drains added to FDA's list of device shortages
July 20, 2022
Sonic Healthcare joins CDC's monkeypox testing push to further grow capacity
July 19, 2022
Diagnostic sector faces a 'challenging set-up' amid economic slowdown: analysts
July 19, 2022
Notified bodies have yet to issue MDR certificates for 85% of legacy devices: survey
July 18, 2022
Illumina fails to block EU antitrust review of $8B Grail merger
July 18, 2022
Abbott, Intuitive, J&J to kick off quarterly earnings season next week as recession threat looms
July 15, 2022
Lack of payment pathway clarity hinders digital therapeutics, analysts say
July 15, 2022
Rising procedure volumes boost hopes for Abbott, J&J as orthopedics lag, survey finds
July 14, 2022
Labcorp launches blood test for neurodegenerative disease biomarker
July 14, 2022
Abbott gets FDA breakthrough tag for deep brain stimulation system in depression
July 13, 2022
Medtronic lands option to buy artery disease player CathWorks for up to $585M
July 13, 2022
CMS makes 'market-moving proposals' to some medtech Medicare rates, say analysts
July 12, 2022
Hologic, Thermo Fisher roll out respiratory panels for Europe ahead of cold and flu season
July 12, 2022
European Commission targets spring of 2024 for fully functional Eudamed database
July 11, 2022
Ex-Mazor executive charged by SEC with insider trading over Medtronic's $1.6B buyout
July 11, 2022
Labcorp starts offering monkeypox testing using the CDC's PCR test
July 8, 2022
High-risk IVD tests rules finalized by European Commission despite industry calls for change
July 8, 2022
Semiconductor shortage leaves medtech industry 'more pessimistic' as customers leave, says Deloitte
July 7, 2022
Intuitive's ecosystem is making it harder for J&J, Medtronic to crack robotic surgery market, say analysts
July 7, 2022
Wearables are a growing part of doctor-patient talks for cardiac patients: study
July 6, 2022
'Little sign' that digital tools are being deployed effectively in fight against COVID outbreak, study finds
July 6, 2022
American Contract Systems' COVID-19 test recall gets Class I label from FDA
July 5, 2022
AliveCor ECG patent ruling sets stage for block on Apple Watch imports
July 5, 2022
LiveMetric's blood-pressure 'smartwatch' device gets FDA clearance
July 1, 2022
Intuitive secures FDA clearance for lung biopsy robot featuring Siemens' imaging tech
July 1, 2022
GE Healthcare powers Cleveland Clinic imaging spinout to $33M financing round
June 30, 2022
Cue Health cuts 170 jobs amid 'economic challenges,' decline in COVID-19 testing
June 28, 2022
BD recalls emergency vascular access devices over risk of delayed care
June 27, 2022
Medtech M&A falls 85% but activity could rebound in second half: report
June 24, 2022
Baxter ventilator recall labeled Class I event by FDA after 2 deaths
June 24, 2022
Bioventus agrees to staggered payment plan to close stalled $315M CartiHeal takeover
June 23, 2022
FDA opens consultation on tissue removal devices to reduce cancer risk
June 22, 2022
Lack of clinical evidence 'major gap' in digital health: study
June 22, 2022
ZimVie faces challenges in focus on slow-growing, 'highly competitive' spine market: JP Morgan
June 21, 2022
Senseonics lands CE mark for 6-month CGM implant, teeing up Q3 launch in Europe
June 17, 2022
Boston Scientific inks $230M deal to buy majority stake in M.I.Tech
June 16, 2022
Medtronic's Martha says supply chain woes may ease in second half
June 16, 2022
Apple Watch monitoring features for AFib, Parkinson's cleared by FDA
June 14, 2022
Dräger's breathing system filter recall gets Class I label from FDA after ventilation obstruction
June 13, 2022
Medical device companies to curb spending as recession threat clouds longer-term outlook: analysts
June 13, 2022
ResMed warns supply constraints may last 18 months after Philips completes recall of sleep-apnea devices
June 10, 2022
UnitedHealth links CGM use in people with Type 2 diabetes to improved blood sugar control
June 10, 2022
Insulet targets competitive conversions as Omnipod 5 insulin pump nears full launch
June 9, 2022
GE Healthcare ventilator battery recall tied to over 1,500 complaints
June 8, 2022
FDA mulls pilot program on alternative sterilization for medical devices
June 8, 2022
Pear sets out payer strategy as it seeks to quadruple prescriptions of digital therapeutics
June 7, 2022
DHS warns cybersecurity vulnerabilities in Illumina software could affect test results
June 6, 2022
Abbott, Medtronic make case for key diabetes products in ADA presentations
June 6, 2022
Getinge's recall of 69,000 stents labeled as Class I event by FDA amid complaints, injuries
June 3, 2022
GE Healthcare says contrast media production back to full capacity
June 3, 2022
BD's Pyxis medication dispenser gets fifth DHS cybersecurity alert in 5 years
June 1, 2022
Recalled devices surged in first quarter, driven by BD connectors
June 1, 2022
Boston Scientific would be 'good fit' for increasingly acquisitive J&J, analysts say
May 31, 2022
Abbott's Libre 3 glucose monitor gets FDA clearance as CGM market intensifies
May 31, 2022
Abbott's imaging catheter recall gets Class I label from FDA over vascular injury risks
May 27, 2022
Baxter raises forecasts for Hillrom synergies, allaying concerns over $10.5B takeover
May 26, 2022
Verily advances smartwatch toward Parkinson's clinical trial use after validating technology
May 25, 2022
Medtech companies keep supply, staffing challenges in check even as recession risks loom: analysts
May 24, 2022
Appeals court sides with Intuitive over J&J in surgical device patent disputes
May 24, 2022
Senate seeks to reform diagnostic oversight via user-fee bill, sparking mixed response
May 23, 2022
Edwards posts 97% success rate with tricuspid device in 30-day test as it prepares for Abbott rival
May 20, 2022
Study shows that Abbott's Amulet, Boston Scientific's Watchman devices are riskier for women
May 19, 2022
Medtronic links renal denervation to increased time below blood-pressure threshold
May 18, 2022
LabCorp becomes first company to get EUA for direct-to-consumer test for flu, RSV, COVID-19
May 18, 2022
FDA posts Class I recall report for 51,000 rapid antigen COVID-19 tests
May 16, 2022
FDA needs testing enforcement discretion policy to improve crisis response, GAO finds
May 13, 2022
Hologic gets FDA approval to challenge Abbott, Roche in transplant testing market
May 12, 2022
Medtronic completes Intersect acquisition following FTC order
May 11, 2022
Rising Google searches for procedures suggest recovering demand at medtechs: analysts
May 11, 2022
FDA finalizes guidance on clinical feasibility studies of diabetic glycemic control devices
May 9, 2022
EU task force posts guidance on significant IVDR changes to address a top priority for industry
May 6, 2022
FDA reveals another Class I COVID-19 test recall as SML pulls 209,000 kits from the market
May 5, 2022
FDA clears Abbott's 4-in-1 Alinity PCR test for sexually transmitted infections
May 5, 2022
Biden should send 'clear' message to semiconductor industry on prioritizing medtech, AdvaMed says
May 4, 2022
Boston Scientific's Watchman FLX shows higher success rate than predecessor, boosting Abbott rivalry
May 4, 2022
Hologic, Thermo Fisher, Qiagen quarterly sales beat estimates on COVID-19 test revenue
May 3, 2022
FDA labels Celltrion's latest recall of 310,000 COVID-19 tests as a Class I event
May 2, 2022
ACLA, AdvaMed urge Congress to immediately replenish COVID-19 testing fund
April 28, 2022
HHS inspector general rules physician-owned device company poses a low risk of fraud and abuse
April 26, 2022
Philips commits more cash to recall as DOJ issues subpoena
April 25, 2022
FDA warns about noninvasive prenatal tests, but analysts see minimal industry impact
April 22, 2022
Medtech survey finds widespread cybersecurity noncompliance despite rising investment
April 21, 2022
Persistent procedure backlogs point to boost for Stryker and Zimmer: analysts
April 21, 2022
Philips investigates reports of 1 death, 4 injuries potentially tied to ventilator recall
April 20, 2022
FDA authorizes first COVID-19 breathalyzer test, clearing path to 3-minute results
April 18, 2022
Digital health funding dropped in Q1 to lowest level since 2020: CB Insights
April 14, 2022
With IVDR looming, EU prioritizes guidance on legacy devices and Eudamed transition
April 13, 2022
Abbott, Intuitive and J&J start medtech earnings season against a turbulent backdrop
April 12, 2022
After seeing reprocessed duodenoscope contamination data, FDA pushes for switch to disposable
April 6, 2022
Medtronic posts positive 3-year data in renal denervation ahead of pivotal readout
April 5, 2022
iRhythm builds case for wearable cardiac monitor with data in fainting, TAVR patients
April 4, 2022
Modeled TAVR volumes recover but still lag Q1 expectations for Edwards: Jefferies
April 4, 2022
Notified body update dampens hopes of near-term surge in IVDR capacity
March 30, 2022
FDA asks Congress for 14% bump in device budget for supply chain, cybersecurity programs
March 29, 2022
Plaintiffs sue Ellume over 'ill-gotten gains' from recalled COVID-19 tests
March 28, 2022
MDR updates safety, clinical performance requirement for high-risk devices
March 28, 2022
Stryker, Zimmer don't expect near-term titanium supply impact from Russia-Ukraine war
March 25, 2022
Another Philips ventilator recall gets Class I label from the FDA
March 23, 2022
Dexcom's hospital glucose monitor leads latest FDA breakthrough designations
March 22, 2022
Illumina sues Guardant CEOs over trade secrets, sparking counterblast against 'retaliatory' lawsuit
March 18, 2022
As White House warns of 'squandering' gains, AdvaMed sets out plan to sustain COVID-19 test capacity
March 17, 2022
US replaces EU as priority market for medtech industry: survey
March 16, 2022
Steep drop in medical device reports on Bayer's Essure in 2021, FDA data show
March 15, 2022
Apyx's surgical device gets FDA warning on off-label skin procedure use
March 15, 2022
Medtronic, Nevro boosted by expansion of Medicare coverage for diabetic pain devices
March 9, 2022
Panel warns against 'knee-jerk' rejection of globalization, calls for medical supply chain transparency
March 7, 2022
FDA final guidance presses industry to be 'recall ready'
March 4, 2022
Celltrion recalls 1.2M rapid COVID-19 tests for improper labeling
March 2, 2022
FDA's performance against MDUFA IV decision goal falls to new low
March 1, 2022
HHS sets out plans to make medical device, diagnostics supply chains pandemic-proof
Feb. 28, 2022
Roche's Foundation Medicine gets FDA breakthrough device nod in latest designations
Feb. 25, 2022
Baxter hit with $18M SEC penalty for accounting improprieties
Feb. 24, 2022
Smith & Nephew hires CEO from Siemens Healthineers, forecasts growth for 2022
Feb. 23, 2022
FDA calls device manufacturing expert meeting to discuss quality system harmonization
Feb. 18, 2022
EU issues guidance on high-risk IVDs, surveillance of legacy medical devices
Feb. 17, 2022
Diagnostics M&A expected to be strong in 2022 after dealmaking took off last year
Feb. 16, 2022
Latest Essure data show more patients had device removed
Feb. 15, 2022
Inflationary risk 'manageable' for medtechs, but impact will vary: RBC
Feb. 15, 2022
Senseonics glucose monitor approval overshadowed by 'eye popping' fall in sales forecast
Feb. 14, 2022
FDA plan to harmonize device quality system rules clears OMB review
Feb. 10, 2022
BioCardia, Cook Medical land FDA breakthrough nods in latest designations
Feb. 9, 2022
Roche partner recalls illegally imported rapid COVID-19 tests from US
Feb. 7, 2022
Abiomed posts record revenues despite COVID-19 waves bookending the quarter
Feb. 4, 2022
CDRH targets hiring, novel approvals among 2022-2025 strategic priorities
Feb. 4, 2022
Siemens Healthineers ups 2022 forecast after COVID-19 test boom, but sees increased competition
Feb. 3, 2022
Edwards-backed Corvia fails pivotal heart failure trial but clings to subgroup efficacy signal
Feb. 2, 2022
Breakthrough device program 'far exceeding' FDA expectations after record year
Feb. 1, 2022
FDA must improve medical device interoperability through data standards: JAMA
Jan. 31, 2022
iHealth Lab gets DoD order for additional 104M home COVID-19 tests
Jan. 31, 2022
Senators urge FDA to finalize over-the-counter hearing aid rule
Jan. 28, 2022
Philips' problems grow as FDA labels expanded ventilator recall Class I event
Jan. 27, 2022
FDA finalizes two guidances on including patient perspectives in medtech clinical trials
Jan. 26, 2022
Medtronic gets earlier-than-expected FDA approval for pain device, raising concerns among Nevro investors
Jan. 25, 2022
Philips targets Q4 2022 end to recall as supply chain issues drag down results
Jan. 24, 2022
Boston Scientific, Sterigenics start tracking ethylene oxide emissions under new EPA rules
Jan. 21, 2022
Digital health funding jumps to new high as investors bet big on mental health startups: report
Jan. 21, 2022
Exact Sciences posts positive data on Cologuard 2.0 ahead of readouts on rival tests
Jan. 20, 2022
FDA misses MDUFA V deadline after months of contentious talks
Jan. 19, 2022
Digital therapeutics face barriers to growth as Pear takes early steps toward sales targets
Jan. 19, 2022
FDA advises physicians to consider alternatives to Endologix AFX2 endovascular grafts
Jan. 14, 2022
Medtech M&A, IPOs hit new highs as more buyers enter the space: SVB
Jan. 14, 2022
Neurological devices, diagnostics dominate latest FDA breakthrough designations
Jan. 13, 2022
Notified body shortage remains pressing as industry prepares for staggered IVDR rollout
Jan. 13, 2022
FDA seeks feedback on draft device shortage guidance
Jan. 12, 2022
Edwards seen falling short in Q4 based on early US TAVR volume data: Jefferies
Jan. 11, 2022
Insurers will be required to cover 8 at-home COVID-19 tests per month
Jan. 11, 2022
Hologic tops guidance as COVID-19 testing wave delivers another beat
Jan. 10, 2022
Quidel preliminary Q4 revenue beats Street on COVID-19 test sales
Jan. 7, 2022
Abbott targets consumer health, aims to turn diabetes success into wearable growth driver
Jan. 7, 2022
Abbott, Quidel COVID-19 antigen tests found to lag PCR in detection of omicron
Jan. 6, 2022
Quest's COVID-19 test results turnaround hits longest wait since 2020
Jan. 6, 2022
Medtechs brace for hit as hospitals warn of omicron impact on surgeries
Jan. 5, 2022
Roche, Siemens at-home tests get EUAs as US faces COVID-19 testing shortage
Jan. 4, 2022
FDA seeks feedback on 180-day notice period for termination of COVID-19 EUAs
Dec. 23, 2021
CDRH warns review timelines will remain extended in 2022 as pandemic pressures continue
Dec. 22, 2021
Most COVID-19 medical device EUAs lack documented supporting data: JAMA
Dec. 21, 2021
EU finalizes staggered rollout of IVDR, removing near-term threat to diagnostic supply
Dec. 21, 2021
At an 'inflection point,' Smith & Nephew predicts faster growth will follow current challenges
Dec. 20, 2021
FDA floats independent contractor to track MDUFA hiring following medtech pressure
Dec. 9, 2021
Study finds surgery volumes bounced back after 2020 COVID-19 shutdown, confirming medtech sales trends
Dec. 9, 2021
Study links cochlear implants to new bone formation, long-term residual hearing loss
Dec. 8, 2021
Implantable cardioverter defibrillators are underused in women, racial minorities: study
Dec. 8, 2021
Cancer treatments lead latest FDA breakthrough device designations
Dec. 7, 2021
Thermo Fisher, Verily on FDA list of COVID-19 tests affected by omicron variant
Dec. 6, 2021
Biden orders private health insurers to cover COVID-19 home tests
Dec. 3, 2021
NuVasive resumes US shipments of titanium-based orthopaedic devices, gets FDA thumbs up
Dec. 2, 2021
EU finalizes implementing regulation for Eudamed medical device database
Dec. 2, 2021
Cyber playbook sets out strategies for modeling threats to medical devices
Dec. 1, 2021
FDA finds 'low likelihood' omicron will impact COVID-19 PCR, antigen tests
Dec. 1, 2021
FDA updates eSTAR ahead of expanding filing template for De Novo submissions
Nov. 30, 2021
BD test, others among rapid antigen kits authorized for one-time use by FDA
Nov. 29, 2021
IVDR milestone as EU expert panel delivers first opinion on a diagnostic submission
Nov. 29, 2021
4 takeaways from Medtronic's latest earnings report
Nov. 24, 2021
FDA resumes domestic surveillance inspections as omicron cases decline
Nov. 23, 2021
Rise of TAVR increased overall aortic valve replacement, improved outcomes: study
Nov. 23, 2021
Latest breakthrough device designations go to brain-computer interface, exo-suit
Nov. 22, 2021
FDA shakes up hepatitis C testing market by opening up 510(k) pathway
Nov. 22, 2021
Stryker dismisses robotics threat from J&J, Zimmer with bullish forecast
Nov. 19, 2021
Medtronic leadless pacemaker flagged by FDA for safety risks
Nov. 18, 2021
TAVR uptake in US cities tied to race, ethnicity and income: JAMA study
Nov. 18, 2021
MCIT breakthrough device payment pathway included in Cures 2.0 bill
Nov. 17, 2021
Siemens Healthineers projects revenue jump fueled by Varian double-digit sales growth
Nov. 17, 2021
Globus in takeover talks with NuVasive to boost spine portfolio: reports
Nov. 16, 2021
BD's $2B annual M&A war chest, connected care devices at heart of growth plan
Nov. 15, 2021
FDA panel finds need for surveillance of devices from Endologix, Medtronic and others
Nov. 15, 2021
Siemens software vulnerabilities potentially put millions of medical devices at risk
Nov. 11, 2021
Medtech sounds alarm on semiconductor shortages, asks feds to prioritize chips for medical use
Nov. 10, 2021
Coloplast acquires laryngectomy device maker Atos Medical in $2.5B takeover
Nov. 10, 2021
CMS repeals MCIT breakthrough device final rule, leaves open other coverage pathways
Nov. 9, 2021
Robotics startup Vicarious files pre-submission with FDA, fresh from $220M SPAC raise
Nov. 9, 2021
Latest Abbott, Boston Scientific LAAC devices yield mixed results in first clinical comparison
Nov. 8, 2021
Edwards, Medtronic bolster economic, clinical case for using TAVR over surgery
Nov. 8, 2021
Stryker, Zimmer, Smith & Nephew warn orthopaedic headwinds to last into Q4
Nov. 5, 2021
FDA issues long-awaited draft software guidance in overhaul of 16-year-old policy
Nov. 4, 2021
Outset nabs first CMS home dialysis add-on payment, setting up fight with Fresenius
Nov. 3, 2021
Safety of Endologix endovascular graft device center of FDA panel review
Nov. 2, 2021
Siemens' Varian leads latest FDA breakthrough device designations
Nov. 1, 2021
3 trends dragging medtechs: Supply chain constraints, inflation and hospital staffing shortages
Nov. 1, 2021
FDA, global peers create guiding principles for AI/ML medical devices
Oct. 29, 2021
FDA restricts breast implant sales, cites Allergan and J&J for inadequate postapproval progress
Oct. 28, 2021
Edwards TAVR volumes tepid in October, quashing hopes of fast recovery from delta
Oct. 28, 2021
FDA's 2022 A-list guidance plan hits on software, post-pandemic future
Oct. 27, 2021
Notified bodies join chorus of criticism of proposed European AI regs
Oct. 26, 2021
EU task force calls for MDR legacy device surveillance requirements
Oct. 25, 2021
Abbott, Intuitive, J&J set tone for earnings: Testing up, procedures down
Oct. 21, 2021
In last ditch plea to save MCIT, medtech groups suggest fixes to CMS
Oct. 20, 2021
Abbott software causing COVID-19 test false positives, starts Class I recall fix
Oct. 19, 2021
Medtronic misses bid for early FDA OK in renal denervation, stock slides
Oct. 18, 2021
The European Commission has caved to pressure on extending IVDR. Now what?
Oct. 15, 2021
Boston Scientific, Sterigenics potential targets of EPA ethylene oxide reporting requirements
Oct. 14, 2021
Withings gets FDA nod for AFib-detecting wearable, taking on Apple
Oct. 13, 2021
FDA breakthrough nods go to liquid biopsies for Alzheimer's, cancer drug response
Oct. 12, 2021
European Commission adds 2 modules to delayed Eudamed database, with no follow-on timeline
Oct. 12, 2021
4 takeaways from a bumper year of M&A medtech activity (so far)
Oct. 11, 2021
FDA beefs up surgical stapler oversight after injuries, death reports
Oct. 8, 2021
FDA labels Ellume's recent COVID-19 Home Test recall Class I event
Oct. 6, 2021
EU shares guide to MDR's 22 rules for classifying medical devices
Oct. 6, 2021
FDA resists industry push to nix De Novo inspections in final rule
Oct. 5, 2021
Acon gets FDA nod for home COVID-19 test kit amid surging US demand
Oct. 5, 2021
FDA hits nearly all MDUFA IV commitments despite pandemic disruptions
Oct. 4, 2021
AdvaMed defends J&J in $344M row with California court over mesh marketing
Oct. 1, 2021
Siemens gets FDA clearance for 'major' improvement to CT imaging
Oct. 1, 2021
Bayer posts final analysis of Essure adverse events to FDA
Sept. 30, 2021
MedTech Europe director warns about EU's turbulent switch to IVDR
Sept. 30, 2021
FDA medical device regs, safety checks questioned by AMA ethics journal
Sept. 29, 2021
FDA starts review after study finds Boston Scientific's Watchman is riskier in women
Sept. 28, 2021
Amid pandemic, medtech R&D, merger activity jumped: EY report
Sept. 27, 2021
Cue, Google's COVID-19 test provider, raises $200M in IPO
Sept. 27, 2021
Medtechs face supply chain disruptions from semiconductor shortage: report
Sept. 24, 2021
FDA tells COVID-19 test makers to assess impact of variants in new EUA conditions
Sept. 24, 2021
FDA categorizes Cordis catheter recall linked to 8 injuries as Class I event
Sept. 23, 2021
EU threatens Illumina for closing $8B Grail deal while still under review
Sept. 22, 2021
Paige's AI-based software gets FDA nod to help doctors identify prostate cancer
Sept. 22, 2021
Abbott gets FDA nod, faces uphill climb taking on Edwards, Medtronic in TAVR market
Sept. 21, 2021
Thermo Fisher COVID-19 testing forecast tops estimates, crushes 2022 guidance
Sept. 20, 2021
FDA warns of false positive risk of Abbott COVID-19 lab tests
Sept. 20, 2021
FDA policy in response to COVID-19 offers blueprint for regulation of LDTs: study
Sept. 17, 2021
Philip Morris takes control of Vectura amid pushback against acquisition
Sept. 17, 2021
Hong Kong-based Prenetics to go public in US as part of $1.25B SPAC merger
Sept. 16, 2021
FDA creates new office to drive forward digital transformation strategy
Sept. 16, 2021
Medtronic-Axonics neuromod IP fight sees another split patent board ruling
Sept. 15, 2021
Zimmer latest medtech to warn of delta wave drag in Q3
Sept. 15, 2021
CMS moves to scrap MCIT rule due to clinical evidence concerns
Sept. 14, 2021
NuVasive warns of delta hit in Q3 as hospitals once again limit electives
Sept. 14, 2021
MedTech Europe calls for urgent clarification of EU artificial intelligence proposal
Sept. 13, 2021
FDA ends summer with fresh batch of breakthrough device designations
Sept. 10, 2021
Spine devices, recalls and endovascular stents on FDA's fall meeting lineup
Sept. 8, 2021
EU expert panel starts accepting applications to review high-risk IVDs
Sept. 7, 2021
Abbott, Quest, Quidel scramble to add test capacity as delta variant surges
Sept. 3, 2021
Smoking pot before knee, hip replacements linked with more complications
Sept. 2, 2021
Cancer diagnoses stayed low even as initial COVID-19 crisis eased: Quest
Sept. 1, 2021
Abbott's Amulet trial results could lift LAA closure market: analysts
Aug. 30, 2021
Boston Scientific's Watchman riskier for women, registry finds
Aug. 30, 2021
BD gets emergency FDA nod for smartphone-enabled COVID-19 test
Aug. 27, 2021
Philips cleared by FDA to start repairing recalled sleep apnea devices
Aug. 27, 2021
Abbott predicted to quickly take share from Boston Scientific's Watchman: survey
Aug. 26, 2021
EU builds out MDR, IVDR guidance ahead of flurry of implementing acts
Aug. 24, 2021
SPAC slashes value of LumiraDx merger by $2B on falling COVID-19 testing forecast
Aug. 23, 2021
TAVR sites concentrated in urban areas linked to mortality risk, study finds
Aug. 20, 2021
EU launches probe of Illumina decision to close Grail deal despite ongoing investigation
Aug. 19, 2021
Abiomed leads latest FDA breakthrough designations for heart disease devices
Aug. 19, 2021
Industry pitches FDA with 26% rise in user fee funding in MDUFA V negotiations
Aug. 18, 2021
Boston Scientific's vaginal mesh studies entrench FDA's view that risks outweigh benefits
Aug. 17, 2021
Memic inks SPAC merger, lining up $360M to challenge Intuitive for robotic surgery market
Aug. 16, 2021
US now a priority market for most developers of novel devices, FDA survey finds
Aug. 13, 2021
NESTcc seeks feedback on active postmarket medical device surveillance system
Aug. 13, 2021
Study reveals stroke risk that brought down Medtronic's HeartWare HVAD
Aug. 12, 2021
Boston Scientific gets FDA nod for single-use bronchoscope, sees $2B opportunity
Aug. 11, 2021
'Evidence gaps' spur CMS to call meeting to discuss cerebrovascular devices
Aug. 11, 2021
Philip Morris buys developer of inhaled heart attack drug, ramping up push into healthcare
Aug. 10, 2021
FDA puts Class I label on Boston Scientific recall estimated to affect one-third of pacemaker line
Aug. 9, 2021
ResMed reaffirms Philips recall is up to $350M boost but held back by supply chain struggles
Aug. 6, 2021
Nevro shares plunge 25% after sluggish Q2, execs brace for worse to come
Aug. 5, 2021
Rival to Boston Scientific's Sentinel meets skeptics at FDA advisory panel
Aug. 4, 2021
Philips ventilator recall labeled Class I by FDA, second in as many weeks
Aug. 4, 2021
Boston Scientific, Stryker get extra year of add-on payments as CMS adjusts to pandemic
Aug. 3, 2021
Digital health, heart disease devices feature in latest FDA breakthrough designations
Aug. 2, 2021
Pent-up demand drives Edwards' TAVR sales past forecasts, but slowdown predicted
July 30, 2021
Siemens Healthineers' diagnostic sales soar on EU demand for COVID-19 tests
July 30, 2021
Supply constraints stymie Smith & Nephew's ortho recovery
July 29, 2021
Talk of Baxter-Hillrom tie-up grows as both companies focus on connected care
July 29, 2021
Quidel to transfer heart failure assay to Beckman Coulter to end litigation
July 27, 2021
PerkinElmer inks $5.3B takeover of antibody provider BioLegend
July 27, 2021
Boston Scientific, Zimmer Q2 expectations lifted by Abbott, J&J, Intuitive results
July 26, 2021
Philips Q2 hit from sleep apnea, ventilator recall overshadows pandemic recovery
July 26, 2021
Illumina-Grail merger subject of in-depth EU antitrust probe
July 23, 2021
FDA seeks funds, powers to fix 'great weaknesses' in medical device supply chain
July 22, 2021
Radiation therapy 'under attack' from CMS cuts, professional body warns
July 21, 2021
PacBio inks $800M Omniome buyout to expand into short-read sequencing
July 21, 2021
Nevro gets FDA nod for diabetic neuropathy treatment but misses Q2 sales target
July 20, 2021
Abbott, Intuitive and J&J kick off medtech earnings as COVID-19 bellwethers
July 19, 2021
NuVasive's scoliosis system gets reinstated CE mark, new instructions for use
July 16, 2021
FDA grants Curative request to revoke COVID-19 test EUA, company pivots to Abbott kits after false result risk
July 16, 2021
Kiwa Cermet Italia becomes 21st notified body under MDR amid capacity concerns
July 15, 2021
Transmedics wins premarket approval for OCS liver system, adding to recent FDA nods
July 15, 2021
Pacemaker implantation after aortic valve replacement linked to mortality risk
July 14, 2021
TransMedics stock halted in Nasdaq trading ahead of FDA advisory panel meeting
July 13, 2021
MDUFA talks expose 'fundamentally different' views of FDA and device companies
July 12, 2021
Abbott's Alere settles with DOJ for $38.75M over defective coagulation test allegations
July 9, 2021
FDA flags biocompatibility concerns linked to NuVasive's Precice devices
July 9, 2021
Quidel COVID-19 PCR recall dubbed Class I by FDA due to false negative risk
July 8, 2021
Stryker inks $15M settlement to resolve Conformis patent dispute
July 8, 2021
EU experts challenge notified body in first opinion on clinical evidence under MDR
July 7, 2021
FDA finalizes guidance on form, content of unique device identifiers
July 7, 2021
As EU-wide health technology oversight law nears passage, industry is not pleased
July 6, 2021
Neuromodulation and cancer devices feature in latest batch of FDA breakthrough nods
July 2, 2021
PMA apps could hit record in 2021, pressuring a pandemic-stressed FDA
July 2, 2021
Supreme Court redefines limits on patent attacks by inventors in Hologic decision
June 30, 2021
Nevro's painful diabetic neuropathy data marred by disappointing Q2 forecast
June 28, 2021
Lawmakers reintroduce diagnostic regulation bill that split the industry
June 25, 2021
EU clarifies Eudamed rules for legacy and custom-made devices
June 25, 2021
Medicare lacks cyber oversight of hospitals' networked medical devices: OIG
June 24, 2021
Contentious device breakthrough payment rule codified in Cures 2.0 proposal
June 24, 2021
Pear secures $400M to scale up digital therapeutic business in SPAC deal
June 23, 2021
Philips recall could be $300M opportunity for ResMed: analysts
June 22, 2021
UK extends OK of Innova COVID-19 test criticized by FDA in warning letter
June 18, 2021
FDA seeks feedback on distinction between device remanufacturing and servicing
June 18, 2021
LetsGetChecked receives EUA for use of at-home COVID-19 collection kit by minors
June 16, 2021
MedPAC says lower clinical lab fees don't impact access, prompting ACLA ire
June 16, 2021
FDA advisory panel to review TransMedics' liver preservation device
June 15, 2021
Abbott's Panbio antigen test misses half of asymptomatic COVID-19 cases in Irish study
June 15, 2021
FDA rejects Verily filing for wrist-worn Parkinson's clinical trial device
June 14, 2021
EC issues medtech guidance on implant cards required under MDR
June 14, 2021
FDA blasts Innova for shipping unapproved COVID-19 test, using false or misleading labeling
June 11, 2021
Medtronic's FDA approval sets up fight for recharge-free pain market
June 11, 2021
EU provides plan to meet 'serious challenge' of readiness for IVDR
June 10, 2021
Amazon offers COVID-19 test online to consumers with a website for viewing results
June 9, 2021
OraSure gets EUAs to enter shrinking COVID-19 antigen test market
June 8, 2021
Medtronic lands FDA approval for brain stimulation leads it expects to drive share gains
June 8, 2021
Cancer tech dominates FDA's latest batch of breakthrough devices
June 7, 2021
Grail starts selling multi-cancer liquid biopsy Galleri in the US
June 7, 2021
Dexcom shares clinical data on G7 CGM ahead of next-gen showdown with Abbott
June 4, 2021
FDA warns device makers of falsified records at Italian ethylene oxide sterilization facilities
June 3, 2021
Cognoa's machine learning software for autism diagnosis gets FDA nod
June 3, 2021
Abiomed buys preCARDIA to bag breakthrough heart failure device
June 2, 2021
FDA seeks 8% budget boost for CDRH to back resurgence of domestic device production
June 1, 2021
ACLA appeals dismissal of PAMA lawsuit, pushes legislative fixes
June 1, 2021
Swiss medtech sounds alarm as MDR erects barriers to EU market
May 28, 2021
Medtronic steps up robotics bet as its challenger to Intuitive starts clinical trial
May 28, 2021
Analysts tip Edwards' US TAVR growth at 90% in April
May 27, 2021
FDA draft guidances lay out postmarket medical device data requirements
May 27, 2021
Quest partners with Paige to create AI-enabled cancer pathology products
May 26, 2021
MDR is live. Here are 5 things to know on where the rule stands.
May 25, 2021
Boston Scientific recalls venous stents because of migration risk
May 24, 2021
FDA seeks feedback on device ingredient labeling requirements
May 21, 2021
Guidance on safety testing, labeling of devices in MR environments finalized by FDA
May 20, 2021
FDA opposes COVID-19 antibody testing to assess post-vaccination immunity
May 20, 2021
OrbiMed, RA Capital top healthcare investors in Q1: CB Insights
May 19, 2021
US panel trims colorectal cancer screening age, opens door to annual Cologuard use
May 19, 2021
Bayer sees jump in Essure adverse event reports gleaned from social media
May 18, 2021
PerkinElmer inks $155M Immunodiagnostic buyout, continuing deal spree
May 18, 2021
CMS again delays breakthrough device payment rule in nod to skeptics
May 17, 2021
Cue raises $235M to build on point-of-care COVID-19 testing
May 14, 2021
Abbott's Assurity, Endurity pacemakers recall dubbed Class I event by FDA
May 14, 2021
Thermo Fisher, Quest step up K-12 COVID-19 testing as school districts look to safely reopen
May 13, 2021
Lawmakers, industry urge CMS to push breakthrough payment rule as May 15 deadline looms
May 13, 2021
EU plans to impose additional regulations on medtech AI products, other 'high-risk' systems
May 12, 2021
FTC asks Allergan Aesthetics, Soliton for additional information on proposed $550M buyout
May 11, 2021
CMS implementation of breakthrough payment rule may be further delayed: Cowen
May 10, 2021
TAVR readmission rates vary widely between hospitals for unknown reasons: study
May 10, 2021
With MDR nearing, EU updates guidance on transition to Eudamed database
May 7, 2021
FDA shares plan for restarting facility inspections, warns backlog will persist into 2022
May 7, 2021
NeoGenomics inks $390M Inivata buyout to enter liquid biopsy space
May 6, 2021
Nevro raises outlook as neuromodulation market recovers from COVID-19 crisis
May 6, 2021
AI, digital health feature in latest batch of FDA breakthrough device designations
May 5, 2021
Newer TAVR devices linked to lower rate of permanent pacemaker use: study
May 5, 2021
Qiagen braces for COVID-19 testing volatility as sales hold steady in Q1
May 4, 2021
LabCorp inks $150M takeover of Myriad Genetics autoimmune testing unit
May 4, 2021
Siemens raises outlook as COVID-19 antigen tests blast past original sales target
May 3, 2021
CMS finalizes joint replacement pricing extension with input from medtech industry
April 30, 2021
Illumina sues European Commission to block competition probe into Grail buyout
April 30, 2021
Smith & Nephew returns to growth as US hip sales surge
April 29, 2021
CMS pitches extra year of add-on payments for Boston Scientific, Stryker, other devices
April 28, 2021
GE Healthcare grows sales as routine screening, elective procedures return
April 27, 2021
Philips raises guidance as elective procedures exceed pre-pandemic levels
April 26, 2021
Robotics startup Vicarious raises $425M, including from BD, to take on giants
April 16, 2021
FDA scraps Trump-era 510(k) exemption bid in scathing dissection of 'flawed' plan
April 16, 2021
6 medtechs to watch when earnings kick off next week
April 15, 2021
FDA authorizes labs for device conformity testing pilot
April 14, 2021
Mid-sized medtechs hit hardest by pandemic, though sector seen resilient: poll
April 14, 2021
Doubts cast on CPAP efficacy evidence in HHS agency review
April 13, 2021
Lucira gets FDA nod for OTC molecular COVID-19 test
April 13, 2021
FDA puts Medtronic Valiant Navion stent graft recall in Class I category
April 12, 2021
Italy's DiaSorin buys Luminex in $1.8B deal for multiplex molecular testing assets
April 12, 2021
Orthopaedic surgeons see slow volume recovery from COVID-19, tip Stryker to gain in poll
April 9, 2021
Hologic pens $795M Mobidiag buyout to expand in acute care testing
April 9, 2021
12 deaths linked to Class I recall for Medtronic's HeartWare HVAD
April 8, 2021
LumiraDx lands on Nasdaq via SPAC with aim to undercut Abbott on price
April 8, 2021
FDA-medtech consortium offers strategy to boost patient engagement in clinical trials
April 7, 2021
Nevro shares full diabetic neuropathy SCS data as it pursues blockbuster opportunity
April 7, 2021
Digital health funding hits new high after Q1 rich in megadeals
April 6, 2021
Invitae inks $200M Genosity buyout, lands $1.2B investment to expand genetic testing
April 6, 2021
UCLA engineer calls for mitigation of biases of medical devices
April 5, 2021
Liquid biopsies dominate FDA's latest breakthrough device nods
April 5, 2021
Medtronic inks value-based care pact with Spectrum Health
April 1, 2021
FDA links certain breast reconstruction devices to risk of complications
April 1, 2021
FDA updates impact of mutations on COVID-19 tests, adds Cepheid to list of affected products
March 31, 2021
FTC challenges Illumina-Grail deal, putting $7B merger in jeopardy
March 31, 2021
Analysts tip surgeries to rebound. Rising COVID-19 cases threaten those forecasts.
March 30, 2021
Helius gets FDA nod for neuromodulator after pivoting to multiple sclerosis
March 29, 2021
Boston Scientific links just approved liver cancer device to improved survival
March 26, 2021
Abbott, Quest, Roche among cos pitching K-12 COVID-19 test plan to tap into Biden's $10B fund
March 26, 2021
Thermo Fisher pivots COVID-19 approach with air detection, school testing
March 25, 2021
Roche bets COVID-19 vaccination drive to favor PCR over antigen testing
March 24, 2021
Baxter, digital health startups lead pushback against 510(k) exemptions
March 23, 2021
FDA grants EUA to COVID-19 screening device using machine learning
March 22, 2021
EU group proposes minimum standards for rapid antibody COVID-19 tests
March 19, 2021
FDA's 1st full OK to BioFire's COVID-19 test clears shorter path for others
March 19, 2021
Biden commits $12B for COVID-19 testing to reopen schools, address disparities
March 18, 2021
FDA backs home use of COVID-19 tests without data in asymptomatic people
March 17, 2021
FDA touts real-world evidence use by Abbott, Medtronic in analysis of regulatory decisions
March 17, 2021
Bayer posts second analysis of Essure adverse events taken from social media
March 16, 2021
FDA flags false positives from Roche's COVID-19-flu test
March 15, 2021
Quest eyes $2B DTC testing potential to capitalize on 'breakout' consumer growth
March 12, 2021
Docs writing in NEJM push CMS to drop breakthrough payment rule
March 11, 2021
GE Healthcare predicts growth, hike in digital investment as pandemic eases
March 11, 2021
BD, Abbott using apps to ease COVID-19 antigen test data bottlenecks
March 10, 2021
EU remote audits under MDR in doubt as divergent national positions persist
March 10, 2021
Intersect touts CMS coverage changes as boon for patient, physician access
March 9, 2021
Abbott capitalizes on digital health boom with virtual clinic for neuromodulation therapy
March 9, 2021
FDA grants first EUA to at-home OTC molecular test for COVID-19
March 8, 2021
Colfax to split in 2, creating over $1B orthopaedic player
March 8, 2021
Warchests, distressed assets drive medtech M&A flurry early in 2021
March 5, 2021
FDA lays out data modernization action plan
March 4, 2021
FDA clamps down on bogus device 'registration certificates' amid rising use during pandemic
March 4, 2021
FDA breakthrough roundup: Cook Medical is latest in round of cardio-themed nods
March 3, 2021
Agilent strikes $550M Resolution buyout to muscle in on liquid biopsy space
March 3, 2021
Quidel, Eurofins get EUAs as at-home COVID-19 test market heats up
March 2, 2021
Medtronic's HeartWare receives another Class I recall after more patient deaths
March 2, 2021
CMS moves to stop COVID-19 testing denials, cost sharing in private plans
March 1, 2021
FDA OKs device to avert traumatic brain injury during sports
March 1, 2021
NuVasive buys Simplify Medical in play for $2.6B cervical spine market
Feb. 26, 2021
Axonics adds incontinence device to portfolio in $200M Contura takeover
Feb. 26, 2021
UK industry pushes for pre- and post-vaccination roles for COVID-19 antibody tests
Feb. 25, 2021
Nevro predicts resurgent pain implant sales in 2021 after slow start to the year
Feb. 25, 2021
ACLA urges Biden to fund uninsured COVID-19 testing, close coverage loopholes
Feb. 24, 2021
UK adopts medical device legislation, setting stage for new databases and sanctions
Feb. 24, 2021
FDA lays path to weigh virus variant impact on COVID-19 test results
Feb. 23, 2021
FDA starts review of how skin pigmentation affects pulse oximeter results
Feb. 22, 2021
Boston Scientific's ICD recall gets 2nd Class I label from FDA
Feb. 22, 2021
Quidel mulls entering new COVID-19 testing markets after another bumper quarter
Feb. 19, 2021
Smith & Nephew Q4 knee sales plummet, exceeding drops reported by Stryker and Zimmer Biomet
Feb. 18, 2021
FDA approves 3D-printed ankle implant for humanitarian use
Feb. 18, 2021
Exact Sciences-Guardant rivalry in colorectal testing market heats up
Feb. 17, 2021
FDA admits COVID-19 antibody test policy was 'flawed,' offers lessons for future outbreaks
Feb. 16, 2021
In run-up to MDR, EU posts guide to legacy devices in Eudamed
Feb. 15, 2021
Abbott, Medtronic could benefit as spinal cord stim seen rebounding
Feb. 12, 2021
LabCorp warns COVID-19 testing sales could plummet as crisis abates
Feb. 11, 2021
Qiagen shuns M&A that 'dilutes' its focus amid reports of Quidel merger
Feb. 10, 2021
Heart disease devices lead latest batch of FDA breakthrough nods
Feb. 10, 2021
Medicare DME competitive bidding in doubt after failed round: analysts
Feb. 8, 2021
FDA OKs Signifier neurostim device for snoring, sleep apnea
Feb. 8, 2021
Abbott antigen test cuts in-school COVID-19 infections in pilot study, but raises challenges
Feb. 5, 2021
Roche diagnostics revenues up 28% fueled by COVID-19 antigen test demand
Feb. 4, 2021
PerkinElmer predicts sharp falloff in COVID-19 sales this year
Feb. 3, 2021
Death, injuries prompt FDA to call Boston Scientific ICD recall Class I event
Feb. 3, 2021
Siemens Q1 boosted by antigen tests, routine work normalizing
Feb. 1, 2021
Edwards' US TAVR sales fall as COVID-19 disrupts referrals
Jan. 28, 2021
England's NHS moves to boost access to Quidel, Roche, other medtech products
Jan. 27, 2021
Ventilators, imaging drive GE healthcare profits up 27% as procedures even out
Jan. 26, 2021
Philips beats Q4 expectations as COVID-19 boosts connected care, slows procedures
Jan. 25, 2021
Intuitive braces for bumpy 2021 as COVID-19 resurgence hits robotics
Jan. 22, 2021
Abbott antigen test misses two-thirds of COVID-19 asymptomatic cases: CDC
Jan. 21, 2021
Haemonetics inks $510M Cardiva takeover to expand hospital business
Jan. 21, 2021
FDA breakthrough nods go to Alzheimer's devices, cardiovascular products
Jan. 20, 2021
CMS rejects 1st colorectal cancer blood test, tweaks path for Exact, Guardant and others
Jan. 20, 2021
MedTech Europe calls for EU to retain support for digital health post-pandemic
Jan. 19, 2021
Neuromod portfolios advance at Medtronic, Boston Scientific, Abbott
Jan. 15, 2021
Intuitive, J&J, Medtronic and Zimmer talk robotic surgery ambitions: JPM21
Jan. 14, 2021
CMS breakthrough rule called tailwind for Abbott, J&J and Medtronic
Jan. 13, 2021
In medtech win, MDR-IVDR remote audits OK'd amid pandemic pressures
Jan. 12, 2021
California proposes expanding Medicaid coverage of continuous glucose monitors
Jan. 11, 2021
FDA flags COVID-19 false negative risk from virus variant of Thermo Fisher, Applied DNA and Mesa tests
Jan. 11, 2021
PerkinElmer inks $591M Oxford Immunotec buy to challenge Qiagen in TB market
Jan. 8, 2021
New Mexico sues device sterilizer Sterigenics over ethylene oxide emissions
Jan. 7, 2021
French medtechs Carmat, CorWave advance heart failure device plans
Jan. 7, 2021
FDA finalizes speedier medical device pathway alternative to breakthrough status
Jan. 6, 2021
Color raises $167M to scale up US testing and telehealth services
Jan. 5, 2021
FDA flags false negative risk of startup Curative's COVID-19 test
Jan. 5, 2021
Brexit deal creates regulatory barriers to UK-EU medical device trade
Jan. 4, 2021
Medtronic, J&J and Edwards among medtechs to headline at JP Morgan
Jan. 4, 2021
Philips clinical-grade wearable study in early COVID-19 detection gets DoD funds
Dec. 23, 2020
Quidel gets EUA to rival Abbott's rapid, point-of-care antigen test
Dec. 22, 2020
Notified bodies warn MDR certification bottleneck could lead to medical device shortages
Dec. 21, 2020
Breakthrough designations go to renal denervation devices in latest FDA batch
Dec. 16, 2020
Roche and Siemens COVID-19 antibody tests shine in FDA accuracy roundup
Dec. 14, 2020
UK shares post-Brexit device guidance as uncertainty around EU split looms
Dec. 11, 2020
LabCorp gets EUA for first at-home collection COVID-19 test with no prescription
Dec. 10, 2020
Roche, Thermo Fisher ally with COVID-19 vaccine developers on antibody testing
Dec. 10, 2020
Registry finds no link between paclitaxel-coated devices and mortality risk: NEJM
Dec. 9, 2020
Qiagen ups outlook, predicts double-digit non-COVID product growth amid analyst skepticism
Dec. 9, 2020
Quest gets first FDA nod for at-home collection coronavirus-flu combo test
Dec. 7, 2020
Olympus to pay $300M to buy Veran for lung navigation system
Dec. 7, 2020
Siemens COVID-19 test gets high marks on FDA sensitivity list, beating Abbott, BD and Roche
Dec. 4, 2020
EU underscores remote notified body audit policy amid pandemic
Dec. 3, 2020
Everlywell raises $175M to expand at-home health testing, virtual care services
Dec. 3, 2020
CMS finalizes expanded artificial heart, ventricular assist device coverage
Dec. 2, 2020
Zimmer puts up $250M in surgical device deal, Boston Scientific nets $800M in BTG pharma sell-off
Dec. 1, 2020
Nevro Q4 sales to drop as COVID-19 headwinds stiffen: analysts
Dec. 1, 2020
Fitbit data suggests potential for early COVID-19 detection using wearables
Dec. 1, 2020
Grail inks commercial pact with UK government for multi-cancer blood test
Nov. 30, 2020
IVDR notified body count inches up to 5 with TÜV Rheinland designation
Nov. 30, 2020
Medtronic ends earnings season with mixed results vs. TAVR rival Edwards
Nov. 25, 2020
NEJM commentary calls for 510(k)s for OTC hearing aids after senators pan FDA delay to rule
Nov. 23, 2020
Abbott on track to top Q4 CGM sales estimates, rise in US FreeStyle Libre scripts suggests
Nov. 23, 2020
MedTech Europe backs proposed EU Health Union but flags potential hangups
Nov. 20, 2020
Notified bodies report early success with remote audits but challenges remain
Nov. 20, 2020
Older patients less willing to have elective procedures as COVID-19 surges: survey
Nov. 19, 2020
Health insurers, labs point fingers over COVID-19 test coverage and prices
Nov. 19, 2020
iRhythm wearable linked to more afib diagnoses, though road to payer uptake called 'grind'
Nov. 18, 2020
Medtronic trial suggests cryoablation bests drug therapy in atrial fibrillation
Nov. 17, 2020
FDA draft guidance expands electromagnetic compatibility advice for medtechs
Nov. 17, 2020
EU regulators provide 7 rules for classifying diagnostics under IVDR
Nov. 16, 2020
BD's Alaris infusion pumps flagged for cybersecurity vulnerability
Nov. 13, 2020
Dialysis device maker Outset Medical tops revenue targets in first quarter since IPO
Nov. 12, 2020
Qiagen seeks EUA for COVID-19 antigen test aiming for positive results in 2 minutes
Nov. 12, 2020
Remote trials, US-Israel device partnership among pitches in FDA, HHS funding bills
Nov. 11, 2020
UK fleshes out post-Brexit approach to regional medical device marking
Nov. 11, 2020
Quidel, Hologic, other test stocks sink as vaccine result brings hope for pandemic's end
Nov. 10, 2020
Zimmer reports record robot installs, ASC-inspired M&A
Nov. 6, 2020
Guardant beats expectations but warns COVID-19 surges will hurt Q4 growth
Nov. 6, 2020
BD returns to growth on COVID-19 antigen tests, but predicts price erosion
Nov. 5, 2020
Hologic bets on COVID-19 molecular test boon beyond 2021
Nov. 5, 2020
FDA warns of COVID-19 antigen test false positives as report flags Quidel on accuracy
Nov. 4, 2020
CMS finalizes rejection of Baxter, Outset dialysis device add-on payments
Nov. 3, 2020
FDA approves Boston Scientific paclitaxel-coated balloon as sector revives after scrutiny
Nov. 3, 2020
Hologic wins $119M from HHS, DOD to help double COVID-19 test production
Nov. 2, 2020
Illumina defends Grail valuation amid much cheaper Exact-Thrive deal
Oct. 30, 2020
Medtronic to pay $9.2M to settle DOJ influence, kickback allegations
Oct. 30, 2020
CMS competitive bidding process fails to drive expected savings, sparking rethink
Oct. 29, 2020
Smith & Nephew lays path to 10% growth for acquired Integra assets
Oct. 29, 2020
Boston Scientific sales not yet back to growth as Watchman hit compounds COVID-19 impacts
Oct. 28, 2020
USPSTF proposes lowering colorectal cancer screening age in boost to Exact Sciences' Cologuard
Oct. 28, 2020
Exact Sciences stock jumps on cancer detection deals for Thrive, Base Genomics
Oct. 27, 2020
FDA grants 510(k) to Abiomed's artificial lung, teeing up use in COVID-19
Oct. 27, 2020
EU notified body designation pipeline points to IVDR bottleneck
Oct. 26, 2020
Neuromod devices at the fore in latest FDA breakthrough designations
Oct. 23, 2020
Robotic surgery pricier, with no measurable benefit in hernias: Cleveland Clinic trial
Oct. 22, 2020
Edwards TAVR sales grow 6% but Q4 forecast disappoints
Oct. 22, 2020
Thermo Fisher's coronavirus tailwinds swell, outpacing Q3 analyst estimates
Oct. 21, 2020
FDA floats framework to message cybersecurity threats to patients
Oct. 21, 2020
Robotic surgery startups help drive Q3 medical device funding over $5B, an all-time high
Oct. 20, 2020
CMS to cut COVID-19 test pay by 25% for delayed results, labs cry foul
Oct. 16, 2020
Intuitive sees partial Q3 recovery but warns COVID-strained hospital finances continue
Oct. 16, 2020
FDA finalizes guidance on nitinol devices, posts biocompatibility draft
Oct. 15, 2020
Medtronic pits TAVR device against Edwards Sapien 3, eyes challenge to Abbott's MitraClip
Oct. 15, 2020
Qiagen beats sales forecast on COVID-19 growth, but leaves room for skeptics
Oct. 14, 2020
J&J-backed Cue gets $481M to onshore production of rapid COVID-19 test kit
Oct. 14, 2020
J&J US device unit returns to growth, potential bellwether for medtech Q3 earnings
Oct. 13, 2020
De Novo-winning devices often lack effectiveness data, analysis shows
Oct. 13, 2020
Cancer testing drives 2020 medtech IPO surge after slow start
Oct. 12, 2020
Roche, Abbott, LDTs are most used COVID-19 tests as supply chain constraints force labs to diversify
Oct. 9, 2020
Fresenius sees COVID-19 driving dialysis device growth, eyes home care strategy
Oct. 9, 2020
Medtronic shares early data TAVR works in low-risk bicuspid patients
Oct. 8, 2020
Avail raises $100M to let medtech reps remotely oversee surgeries
Oct. 8, 2020
Abbott, on defense, details embattled rapid COVID-19 test results
Oct. 7, 2020
Analysts predict Zimmer Biomet M&A in 2021 to speed growth
Oct. 7, 2020
App-connected pacemakers, telehealth among Cleveland Clinic top 2021 innovations
Oct. 7, 2020
M&A on horizon as deep-pocketed medtechs eye distressed assets: EY
Oct. 6, 2020
Quidel antigen test to detect COVID-19 and flu gets FDA nod
Oct. 5, 2020
AdvaMed sends CMS reform wishlist to boost digital health device coverage
Oct. 2, 2020
Smith & Nephew, Quidel forecasts may signal improving ortho, diagnostics markets
Oct. 2, 2020
AtriCure stock recovers after short seller predicts 'complete collapse' of business
Oct. 1, 2020
FDA flags risk of infection with CardioQuip heater-cooler device
Oct. 1, 2020
Analysis of FDA safety alerts spurs call for changes to medical device adverse event reporting
Sept. 30, 2020
COVID-19 spurred a medtech M&A boom this summer. Will it last?
Sept. 30, 2020
Smith & Nephew inks $240M deal to buy orthopaedic assets from Integra
Sept. 29, 2020
FDA finalizes overhauled guidance on device conformity testing pilot
Sept. 25, 2020
Exact Sciences wows investors with preliminary multi-cancer liquid biopsy data
Sept. 25, 2020
FDA grants EUA to first point-of-care COVID-19 antibody test
Sept. 24, 2020
Quest, Walmart pilot drone delivery of COVID-19 tests
Sept. 23, 2020
Medtronic gets FDA breakthrough tag for device to prevent infections
Sept. 22, 2020
Illumina inks $8B Grail buyout for liquid biopsy market. Investors are not sold.
Sept. 21, 2020
Qiagen completes takeover of PCR automation player NeuMoDx for $248M
Sept. 18, 2020
PerkinElmer tops FDA COVID-19 test sensitivity list, with BD and Roche scoring lower
Sept. 18, 2020
Cellex, Gauss ally to develop fully at-home, app-enabled COVID-19 antigen test
Sept. 17, 2020
Moody's raises medtech outlook amid testing boom at Abbott, Thermo Fisher
Sept. 17, 2020
Intersect ENT strikes €60 Fiagon buyout to expand in balloon sinuplasty
Sept. 16, 2020
NIH funds up to $23M to IBM, Evidation and others for COVID-19 digital health tech
Sept. 16, 2020
Another BD Alaris recall pegged Class I event by FDA
Sept. 15, 2020
Thermo Fisher hikes growth forecast, expects COVID-19 sales to top $3B in late 2020
Sept. 11, 2020
FDA aims to harmonize adverse event reporting with eMDR updates, makes patient problem codes public
Sept. 10, 2020
The best TAVR device? Experts opine on when to use Boston Scientific, Edwards or Medtronic valve
Sept. 10, 2020
Grail files for $100M IPO ahead of 2021 launch of multi-cancer liquid biopsy
Sept. 9, 2020
Ultrasound ablation provided 'adequate' short-term control for prostate cancer patients, small study shows
Sept. 9, 2020
Edwards gets FDA approval for Sapien 3 in new patient population
Sept. 8, 2020
Abbott resurrects resorbable scaffold tech for below-the-knee trial
Sept. 4, 2020
FDA flags 428 spinal cord stimulator patient deaths, urges more tests before implant
Sept. 4, 2020
Watchdog gives high marks to CMS competitive bidding program
Sept. 3, 2020
NIH awards $129M to scale up US COVID-19 testing capacity
Sept. 3, 2020
Roche set to launch rival to Abbott's rapid COVID-19 antigen test
Sept. 2, 2020
UK outlines post-Brexit medical device regime starting January
Sept. 2, 2020
HHS backs COVID-19 antigen testing for nursing homes, preempting regional restrictions
Sept. 1, 2020
Medtronic artificial pancreas gets FDA nod for young kids
Sept. 1, 2020
Comparisons of COVID-19 saliva, swab tests paint mixed picture
Aug. 31, 2020
EU MDR costing smaller medtechs 5% of their annual sales: survey
Aug. 31, 2020
Clinical trial links hospital use of Dexcom G6 to improved glucose control
Aug. 28, 2020
Philips pens $275M Intact Vascular deal to acquire implant
Aug. 28, 2020
Tandem's artificial pancreas improves glucose control in pediatric trial
Aug. 27, 2020
Abbott gets EUA for rapid $5 COVID-19 antigen test
Aug. 27, 2020
Freenome raises $270M to run pivotal trial of colorectal cancer liquid biopsy
Aug. 26, 2020
Hologic inks $80M Acessa buyout to expand women's health business
Aug. 26, 2020
Intuitive robot may up survival in mouth and throat cancers, but not others: study
Aug. 21, 2020
Cold War law invoked for BD, Quidel to prioritize antigen test contracts
Aug. 21, 2020
IDx rebrands, buys 3Derm to expand automated AI portfolio
Aug. 20, 2020
LumiraDx lands FDA's third COVID-19 antigen test EUA, as demand for rapid diagnostics rises
Aug. 20, 2020
Eudamed's first section to go live before year's end
Aug. 19, 2020
Thermo Fisher COVID-19 test flagged for false positive and negative results
Aug. 18, 2020
FDA OKs Yale COVID-19 saliva test removing RNA extraction step
Aug. 17, 2020
Myriad names new CEO, reports sales sank 57% amid COVID-19 shutdowns
Aug. 14, 2020
Hospitals, docs pitch roadmap to keep essential surgeries going even with coronavirus surges
Aug. 14, 2020
Thermo Fisher-Qiagen deal falls apart after failing to secure shareholder support
Aug. 13, 2020
Watchdog again pushes CMS to add UDIs to claim forms
Aug. 13, 2020
FDA posts Essure adverse events pulled from social media
Aug. 12, 2020
Hologic jumps into COVID-19 pool testing, aimed at boosting lab capacity
Aug. 12, 2020
Sientra claims market gains as breast implant sales rebound faster than rivals
Aug. 11, 2020
Struggling Senseonics allies with blood glucose monitoring giant Ascensia, taps much-needed $80M
Aug. 11, 2020
Notified bodies list for incoming EU regs hits 20 with designation of DQS for MDR
Aug. 10, 2020
Guardant growth slows in Q2 but still beats expectations
Aug. 7, 2020
Acutus raises $159M in IPO, challenging medtech leaders for cardiac mapping market
Aug. 7, 2020
Nevro blasts past analyst consensus on rebound in pain procedures
Aug. 6, 2020
Americas drag on Qiagen as Thermo Fisher deal goes down to the wire
Aug. 5, 2020
J&J gets FDA breakthrough status for robot-assisted ablation device
July 31, 2020
Exact Sciences bets pandemic will accelerate adoption of Cologuard
July 31, 2020
Teleflex reports rapid rebound in UroLift sales, driving Q2 beat
July 30, 2020
Falling FDA personnel costs soften 2021 medical device user fee hike
July 30, 2020
Coronavirus could fuel clinical lab M&A by stressing smaller hospital players
July 29, 2020
Smith & Nephew falls short of expectations, citing COVID-19 headwinds
July 29, 2020
Color targets supply, staffing bottlenecks with updated coronavirus test EUA
July 28, 2020
LabCorp COVID-19 test gets 1st FDA OK for asymptomatic screening
July 27, 2020
COVID-19 diagnostics emerging as prime investment target, SVB analysis shows
July 24, 2020
Edwards aims for 5% TAVR sales growth in 2020 after seeing demand bounce back
July 24, 2020
COVID-19 test demand backs 61% jump in Roche molecular diagnostic sales in 2020
July 23, 2020
Medical device deal values down 88% amid COVID-19 disruption: PwC
July 23, 2020
Thermo Fisher rakes in $1.3B in coronavirus-related Q2 revenue
July 22, 2020
AdvaMed launches COVID-19 test registry to address shortages
July 22, 2020
NuVasive surprises analysts with sooner-than-expected spine surgery sales rebound
July 21, 2020
FDA eases rules on viral transport media to boost availability for COVID-19 testing
July 21, 2020
Philips sees double-digit COVID-19 connected care bump amid Q2 sales dip
July 20, 2020
J&J drops planned 510(k) for Verb-Auris robot, targets 2022 clinical trial start
July 17, 2020
J&J device sales fell by one-third in Q2, but June rebound drives better 2020 outlook
July 16, 2020
FDA commits to staggered move to electronic medtech filings
July 15, 2020
FDA proposes BPH device trial guidance changes as market heats up
July 14, 2020
Edwards to pay Abbott $468M to settle mitral, tricuspid repair device patent disputes
July 14, 2020
IVDR implementation by 2022 'highly doubtful,' trade group warns
July 10, 2020
Siemens COVID-19 antibody test beats rivals in head-to-head study
July 10, 2020
Q2 previews show coronavirus diagnostics bump for Thermo Fisher, Quidel, GenMark
July 9, 2020
Philips wins $100M tele-ICU contract from VA
July 9, 2020
FDA warns of false positives with BD coronavirus diagnostic
July 7, 2020
CDC gets FDA nod for coronavirus-flu combination diagnostic
July 6, 2020
FDA delays UDI enforcement amid COVID-19, ongoing technical issues
July 2, 2020
BARDA backs push for clinical-grade wearable to detect signs of COVID-19
July 2, 2020
CMS proposes major market expansion in potential boost for Abbott's MitraClip
July 1, 2020
Notified body poll finds multi-month waits for COVID-19 conformity assessments
July 1, 2020
As Beckman enters US COVID-19 antibody market, how do rivals compare?
June 30, 2020
FDA nod to Boston Scientific cardiac monitor clears challenge to Abbott, Medtronic
June 29, 2020
Medtronic renal denervation registry shows blood pressure improvements persist at 3 years
June 26, 2020
Polares raises $40M to target competitive mitral regurgitation market
June 26, 2020
Move to digital mammography failed to improve outcomes, study finds
June 25, 2020
UK study to validate, compare COVID-19 tests in real-world settings
June 25, 2020
New Guardant genomic database could be worth $2B, analysts say
June 24, 2020
FDA affirms potential to miss MDUFA deadlines, weighs virtual advisory panels
June 23, 2020
Mainstay wins FDA approval for chronic back pain device following mixed clinical data
June 23, 2020
Lack of data encryption for Baxter devices flagged in flurry of DHS alerts
June 19, 2020
FDA cracks down on sellers of at-home COVID-19 antibody tests
June 18, 2020
TÜV SÜD becomes 4th notified body designated under IVDR
June 18, 2020
NIH loops Quest into effort to test 10K Americans for antibodies against coronavirus
June 17, 2020
Endologix stent graft tied to 5 deaths gets high-risk recall label from FDA
June 17, 2020
Heart rhythm bodies see 'clear concerns' with using wearables to detect arrhythmias
June 16, 2020
Labs urge CDC to change COVID-19 antibody test guidelines
June 16, 2020
Abbott's FreeStyle Libre 2 gets long-awaited iCGM nod from FDA
June 15, 2020
CMS to review at-home ventilation of COPD patients amid variability in device use
June 12, 2020
Moody's lowers medtech earnings forecast, pegs J&J, Zimmer among hardest hit by COVID-19 fallout
June 12, 2020
Cue Health raises $100M to scale up rapid, portable coronavirus test
June 11, 2020
MedTech Europe pitches virtual audits to clear MDR coronavirus logjam
June 11, 2020
DOJ charges medtech exec with $69M in COVID-19 test fraud, notes Theranos parallel
June 10, 2020
Ex-FDA chief scientist slams 'chaos' caused by agency approach to antibody tests
June 10, 2020
FDA expands at-home, saliva-based coronavirus testing with nod to Phosphorus
June 9, 2020
Lawmakers push HHS to funnel funds to clinical labs amid routine testing decline
June 9, 2020
COVID-19 false negatives fuel call for urgent focus on asymptomatic patients
June 8, 2020
BARDA, Evidation team on early detection of COVID-19 using wearables
June 5, 2020
FDA warns of cyanide gas risk with certain media if used with Hologic coronavirus test
June 5, 2020
European Commission lays out timeline for next steps toward MDR, IVDR
June 4, 2020
Haemonetics unveils back-to-back divestitures of blood supply assets
June 4, 2020
Fitbit, NASA get latest FDA emergency authorizations for ventilators
June 3, 2020
JAMA reanalysis goes against 5-year Abbott stent study findings, upping odds of death
June 3, 2020
Many heart device trials 'small and fragile,' come with misleading spin: JAMA study
June 2, 2020
US needs 10-fold increase in COVID-19 testing, analysts say
June 2, 2020
Tests to detect cancer, guide treatment heat up with barrage of data at ASCO
June 1, 2020
Widespread shortages for COVID-19 test materials persist, poll says
May 29, 2020
Four deaths trigger Class I recall for parts of Medtronic's HeartWare system
May 29, 2020
Emergency authorization granted to COVID-19 ICU prediction software
May 28, 2020
FDA offers reference panel to validate coronavirus tests amid false negatives
May 28, 2020
Analysts saw 30% drop in TAVR growth in April, but Q2 may be better than feared
May 27, 2020
CDC seeks to limit false positives with COVID-19 antibody testing, as immunity question lingers
May 27, 2020
FDA eases rules on changes to PMA, HDE devices to avoid coronavirus supply disruptions
May 22, 2020
Abbott, Roche ink deals with UK for 10M coronavirus antibody tests
May 22, 2020
Hospitals push FEMA to form broad supply pact with medtech
May 21, 2020
COVID-19 drives EC to change rules on notified body designations
May 20, 2020
Labs welcome CMS rate for coronavirus antibody testing
May 20, 2020
FDA OKs 1st at-home collection kit for use with multiple labs, coronavirus tests
May 18, 2020
Cardiology group ranks best devices for aorto-iliac arterial interventions
May 15, 2020
Abbott on defense as FDA flags false negative reports with point-of-care coronavirus test
May 15, 2020
Philips, startups look to deploy new ultrasound tech amid coronavirus
May 14, 2020
EC outlines clinical trial safety reporting between MDR, Eudamed start dates
May 14, 2020
FDA flags 2nd high-risk recall of embolectomy catheters in recent weeks
May 13, 2020
Eko algorithm gets FDA nod for cardiac screening of COVID-19 patients
May 13, 2020
FDA, CDC drawing up plan to restart routine facility inspections
May 12, 2020
1st antigen test to detect coronavirus gets FDA nod
May 11, 2020
FDA details COVID-19 era reporting rules to stymie medical device shortages
May 7, 2020
Qiagen aims for 50-fold jump in coronavirus test reagent output
May 7, 2020
Notified bodies saw CE marks spike in 2019 ahead of now-delayed MDR
May 6, 2020
Deferred elective procedures wipe out Smith & Nephew revenues, prompting $200M in cost cuts
May 6, 2020
AHA, societies share new roadmap amid restarts to TAVR, other postponed procedures
May 5, 2020
Roche gets emergency OK for coronavirus antibody test
May 4, 2020
Coronavirus surge in critical care sales helps Hillrom beat Q2 guidance
May 1, 2020
Medtronic continuous dialysis system designed for small children gets FDA nod
May 1, 2020
Teleflex yanks guidance as coronavirus craters key product
April 30, 2020
AdvaMed pushes US to lift tariffs on Chinese imports of COVID-19 devices
April 30, 2020
GE reducing healthcare headcount in $700M cost-cutting drive
April 29, 2020
Novocure shares data from post-approval brain cancer device trial
April 28, 2020
FDA tweaks electronic filing guidance amid heavy use of emergency authorization pathway
April 28, 2020
FDA moves to boost access to imaging systems during pandemic
April 24, 2020
FDA grants breakthrough status to heart failure, stent graft tech
April 24, 2020
Senseonics averts cash crunch with $20M loan but future remains grim
April 23, 2020
MedTech Europe pushes for IVDR delay as MDR hold nears finish line
April 23, 2020
Thermo Fisher and Roche enjoy COVID-19 diagnostic tailwinds, but warn of routine testing declines
April 22, 2020
ResMed to get biggest bang out of HHS ventilator contracts, analysts predict
April 21, 2020
Philips to invest $109M as COVID-19 drives connected care order growth
April 20, 2020
EU MDR delay clears Parliament, enters final stages
April 17, 2020
GE, Ford get $336M HHS contract for 50K lower-cost ventilators
April 17, 2020
Pandemic drives US da Vinci robot use down 65%
April 17, 2020
Boston Scientific to begin selling cheaper ventilator alternative
April 16, 2020
Philips launches scaled-down ventilator, inks production deals to boost output
April 15, 2020
J&J blames pandemic for medical device sales slump
April 14, 2020
CMS issues guidance to free patients from copays for coronavirus tests
April 13, 2020
Court sides with Nevro over Boston Scientific in pain device patent dispute
April 10, 2020
Abbott lands CE mark for tricuspid sibling of MitraClip
April 10, 2020
EU permits remote notified body audits during pandemic
April 9, 2020
GM, Philips land $1.1B in HHS ventilator contracts, Medtronic boosts production
April 9, 2020
Harvard, INSEAD authors pitch systemic regulatory approach to AI/ML devices
April 8, 2020
Embolism risk prompts FDA to treat Boston Scientific recall as Class I event
April 8, 2020
FDA OKs changes to oxygenation devices to treat coronavirus patients
April 7, 2020
FDA clears Sectra's digital pathology module for primary diagnostics as US market heats up
April 2, 2020
NuVasive suspends UK sales of Magec rod amid safety concerns
April 2, 2020
Vulnerability in medication dispensing system flagged again by DHS cyber team
April 1, 2020
Stenting matches bypass surgery in 10-year study of left main patients
March 31, 2020
High-risk devices with expedited reviews more likely to be recalled, research suggests
March 31, 2020
Low-risk TAVR: Edwards results taper in 2nd year, Medtronic targets bicuspid market
March 30, 2020
FDA outlines role for 3D printing in coronavirus response, with some caution
March 27, 2020
UnitedHealth says self-swabbing study spurred FDA coronavirus policy change
March 26, 2020
MedTech Europe calls for delay of MDR until coronavirus crisis passes
March 24, 2020
FDA eases rules on ventilator makers as Medtronic and Tesla talk
March 23, 2020
Exact Sciences pulls 2020 sales guidance amid coronavirus uncertainty
March 20, 2020
New notified bodies trickle in ahead of looming MDR start date
March 19, 2020
FDA pulls plug on routine US inspections
March 19, 2020
MedTech Europe sounds alarm over 'inconsistent' enforcement amid flurry of MDR updates
March 18, 2020
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline
March 17, 2020
Natera breaks ties with Qiagen on NGS testing, citing Illumina deal
March 13, 2020
Senseonics cites Freestyle Libre pricing as factor in its Roche deal challenges
March 13, 2020
FDA finalizes contentious guidance on third party 510(k) reviews
March 12, 2020
FDA issues Class I recall for Medtronic's HeartWare HVAD after patient death
March 11, 2020
Key EU notified body meeting goes on, virtually
March 11, 2020
Cardiologist groups back Abbott push to change heart device coverage
March 6, 2020
Axonics execs bullish on breaking Medtronic market stranglehold
March 5, 2020
UK looks to use Brexit to make device industry more transparent
March 5, 2020
Exact Sciences closes takeovers of 2 cancer testing businesses
March 4, 2020
Element Science raises $146M to fund rival to Zoll's wearable LifeVest
March 4, 2020
AdvaMed, Medtronic among top 20 pharma and health product lobbyists over 2 decades: study
March 3, 2020
Olympus-backed Medi-Tate gets FDA nod for prostate device
March 3, 2020
Coronavirus: No US shortages of essential devices yet, as FDA monitors more than 60 companies
Feb. 28, 2020
FDA posts trio of medical device warning letters
Feb. 28, 2020
Psychiatrists plan transcranial magnetic stimulation buys: Wall Street report
Feb. 27, 2020
FDA pilots new 510(k) submission template for device manufacturers
Feb. 27, 2020
LivaNova gets nod for heater-cooler device changes to cut contamination risk
Feb. 26, 2020
FDA bolsters CLIA waiver application recommendations
Feb. 26, 2020
Guardant predicts net loss doubling as it takes on Exact Sciences' Cologuard
Feb. 25, 2020
Cardiovalve gets FDA breakthrough status for tricuspid valve replacement system
Feb. 21, 2020
Ortho, spine players Smith & Nephew, NuVasive and Globus post Q4 results
Feb. 21, 2020
Teleflex strikes $260M deal, gaining parts used in TAVR procedures
Feb. 20, 2020
DHS warns of WannaCry-like vulnerability in Spacelabs Healthcare systems
Feb. 19, 2020
Senseonics' implantable CGM wins Cigna coverage, shares soar
Feb. 19, 2020
FDA tracks uptick in masks, other protective gear in coronavirus update
Feb. 18, 2020
Baxter overstated income by $278M, internal probe finds
Feb. 14, 2020
LabCorp weathers rising personnel costs to beat expectations in Q4
Feb. 13, 2020
FDA folds Cook Medical asks into final peripheral vascular atherectomy device 510(k) guidance
Feb. 13, 2020
FDA OKs 'Inside-Out' device for enabling hemodialysis in hard-to-treat patients
Feb. 12, 2020
Exact Sciences beefs up sales force as it seeks big Cologuard growth in 2020
Feb. 12, 2020
Renewed calls for Impella RCT as JAMA details bleeding, death rate findings
Feb. 11, 2020
Longtime Myriad CEO resigns amid another steep earnings miss, guidance cut
Feb. 7, 2020
Abiomed, on defense, plans wave of trials to counter Impella criticism
Feb. 6, 2020
Qiagen, still independent, limps back from 2019
Feb. 5, 2020
Abbott, SynCardia requests prompt CMS to reconsider heart device coverage
Feb. 5, 2020
Brexit happened. EU MDR looms. 3 key questions on medtech's future in Europe
Feb. 4, 2020
Medtech in limbo as Brexit arrives
Feb. 3, 2020
Edwards saw US TAVR procedures spike 40% in Q4
Jan. 31, 2020
5-year Edwards results: TAVR matches surgery on survival, but repeat hospitalizations more common
Jan. 30, 2020
Major conglomerates 3M, GE, Philips bet on healthcare
Jan. 30, 2020
UK moves to mitigate impact of notified body withdrawals
Jan. 30, 2020
Abiomed device controversy revived in Circulation editorial
Jan. 29, 2020
Natera takes ArcherDX to court over cancer testing patent
Jan. 28, 2020
Philips and ResMed may lose share in growing market for sleep tech: survey
Jan. 28, 2020
Moody's predicts cardiology tech to outpace rest of medical devices, driven by TAVR
Jan. 24, 2020
GE cybersecurity flaw gets maximum risk score, triggering rare FDA notice
Jan. 24, 2020
3 more notified bodies coming soon, EC says as MDR clock ticks down
Jan. 23, 2020
Surgical gown recall sets Cardinal back $96M
Jan. 23, 2020
Medical device sales flat, J&J CEO promises big year for robots
Jan. 22, 2020
Virtual, augmented reality in medicine pique FDA's interest
Jan. 17, 2020
Edwards' US patent challenge to Abbott MitraClip IP denied
Jan. 17, 2020
Study of Abbott's HeartMate 3 points to single treatment indication for LVADs
Jan. 16, 2020
ResMed pays more than $37.5M to settle false claims allegations
Jan. 16, 2020
REVA files for bankruptcy after bioresorbable scaffold flops
Jan. 16, 2020
ArcherDX, Geneoscopy, Phagenesis win breakthrough device designations
Jan. 15, 2020
LabCorp, Quest push for M&A-driven growth despite difficulties closing deals
Jan. 15, 2020
RTI Surgical inks $490M deal to sell OEM unit to private equity
Jan. 14, 2020
Intuitive closes 2019 by topping Q4 expectations
Jan. 10, 2020
JenaValve TAVR tech amid wave to get breakthrough device status from FDA
Jan. 10, 2020
Adaptive gets CMS coverage for chronic lymphocytic leukemia test
Jan. 9, 2020
MedTech Europe pushes urgent action to keep devices on sale after MDR
Jan. 9, 2020
FDA sets new date to talk future data strategy
Jan. 8, 2020
Digital health M&A flatlines in 2019, but IPO activity promising
Jan. 8, 2020
OrthoPediatrics sells Vilex assets in preparation for more M&A
Jan. 7, 2020
NuVasive replaces CFO with former Mallinckrodt executive
Jan. 3, 2020
Illumina scraps $1.2B PacBio takeover amid regulatory pushback
Jan. 3, 2020
Notified bodies MedCert, BSI gain new EU MDR and IVDR designations
Dec. 31, 2019
FDA creates best practices for combination product developers
Dec. 24, 2019
FDA qualifies tool for assessing safety of implanted devices
Dec. 13, 2019
Livongo, Propeller, Omada tapped for Express Scripts digital health formulary
Dec. 13, 2019
EC medical device group sheds new light on MDR, IVDR sampling codes
Dec. 12, 2019
Sanofi pulls back from 'over-invested' virtual diabetes care venture with Verily
Dec. 11, 2019
BioMarin taps Invitae to expand genetic testing for skeletal dysplasia
Dec. 11, 2019
CMR changes CEO ahead of US robotic surgery launch
Dec. 10, 2019
Establishment Labs' breast implant opportunity to triple: Jefferies
Dec. 6, 2019
Roche MRSA test wins FDA De Novo OK
Dec. 6, 2019
FDA grades new Medtronic SynchroMed II recall as Class I event
Dec. 5, 2019
Vicarious' surgical robot gets FDA breakthrough status
Dec. 5, 2019
Boston Scientific afib device effective in reducing stroke
Dec. 5, 2019
FDA grants breakthrough status to eye-tracking Parkinson's test
Dec. 4, 2019
Contract sterilizer of devices draws FDA warning over validation issues
Dec. 4, 2019
Medtronic and Elekta form radiation therapy pacts with ViewRay
Dec. 3, 2019
MRI screening linked to improved detection of breast cancer
Dec. 2, 2019
Intuitive gets FDA go-ahead for robotic system sealing instrument, power generator
Dec. 2, 2019
FDA approves TB test from Qiagen and DiaSorin
Dec. 2, 2019
B. Braun recalls blood sets over risk of leakage and infection
Nov. 27, 2019
Roche facing $137M in damages over diagnostic patent dispute after jury verdict
Nov. 27, 2019
Medtronic warns of fault with MiniMed insulin pumps
Nov. 26, 2019
Merit Medical stent graft system gains breakthrough status
Nov. 22, 2019
Medtronic's recovering DCB segment scores FDA approval of IN.PACT AV
Nov. 22, 2019
Transcatheter device to treat heart failure gets breakthrough designation
Nov. 21, 2019
Pulmonary hypertension common in MitraClip patients, increasing mortality risk: JAMA Cardiology
Nov. 21, 2019
Carolina Liquid gets FDA warning over sale of unauthorized reagents
Nov. 20, 2019
Asian private equity group to buy Lumenis in $1B deal
Nov. 20, 2019
Edwards has edge over Medtronic in TAVR registry studies
Nov. 19, 2019
BARDA backs Inflammatix test to improve antibiotic use
Nov. 15, 2019
BioSig targets 9 installations of cardiac technology in 2020
Nov. 15, 2019
FDA overhauls export certificate guidance after negative feedback
Nov. 14, 2019
Hologic wins FDA approval for AI-based breast imaging tech
Nov. 14, 2019
TransEnterix cuts 18% of staff, doesn't take questions from analysts
Nov. 13, 2019
Paige gets CE mark for prostate cancer detection technology
Nov. 13, 2019
FDA grants breakthrough status to AI-based gastric cancer diagnostic
Nov. 12, 2019
Medtronic reveals high-risk cyber vulnerability in electrosurgical generators
Nov. 8, 2019
Triple-digit liquid biopsy growth powers Guardant to beat-and-raise quarter
Nov. 8, 2019
Medicare overpays for certain orthotic devices, OIG finds
Nov. 7, 2019
After stumble, diabetes drives Livongo to top Q3 estimates
Nov. 7, 2019
Hologic beats sales outlook on diagnostics, breast health
Nov. 7, 2019
FDA authorizes 1st NGS test for HIV drug resistance mutation
Nov. 6, 2019
Myriad shares plunge 40% after missing targets, slashing outlook
Nov. 5, 2019
Medtronic thoracic stent graft system approved in Japan
Nov. 1, 2019
Teleflex raises outlook despite taking $8.7M hit tied to sterilization facility closure
Nov. 1, 2019
Smith & Nephew ups outlook a day before new CEO takes helm
Oct. 31, 2019
Sharp drop in Chinese sales drags Qiagen down in Q3
Oct. 31, 2019
FDA puts J&J's Ethicon surgical stapler recall in top risk category
Oct. 31, 2019
CMS proposes lifting restrictions on NGS cancer testing
Oct. 30, 2019
Surmodics gets breakthrough tag for critical limb ischemia device
Oct. 30, 2019
Sanford agrees to $20M settlement to resolve kickback allegations
Oct. 29, 2019
UK regulator mulls blocking Illumina's $1.2B PacBio takeover
Oct. 25, 2019
Fresenius gets breakthrough tag for clot-preventing dialysis device
Oct. 25, 2019
Rivals LabCorp and Quest post improved outlooks despite PAMA woes
Oct. 24, 2019
Device to ID obstructions in post-PCI patients wins breakthrough status
Oct. 24, 2019
J&J reports rising success rate in robotic surgery clinical trial
Oct. 24, 2019
Device to halt knee implant infections gets breakthrough tag
Oct. 23, 2019
Baird dentist poll suggests stagnant demand for devices
Oct. 23, 2019
Canon gets FDA nod for AI tech to enhance CT images
Oct. 22, 2019
AdvaMed lobbies Trump to repeal medical device tax (again)
Oct. 18, 2019
TransEnterix seeks 'strategic alternatives' amid robot slump, restructuring
Oct. 18, 2019
Researchers question safety benefit of robotic colectomies
Oct. 17, 2019
FDA grants breakthrough status to next-generation PSA test
Oct. 17, 2019
ViewRay bucks payment fears in field dubbed 'not dead' yet
Oct. 16, 2019
Titan scraps filing plan for robotic surgical system amid cash crunch
Oct. 16, 2019
Two weeks from Brexit deadline, UK floats device contingency
Oct. 15, 2019
FDA clears first rapid Ebola virus diagnostic
Oct. 11, 2019
GAO finds low uptake of disposable wound care devices
Oct. 11, 2019
FDA makes final recommendations on vascular device labels
Oct. 10, 2019
Experimental cancer IVD trial guidance finalized
Oct. 10, 2019
Fresenius to pay $5.2M to settle Medicare overbilling allegations
Oct. 10, 2019
Move over gene therapy. Bioelectronics an 'underappreciated' multibillion-dollar market: McKinsey
Oct. 9, 2019
One Drop makes Walmart debut
Oct. 9, 2019
Livongo scores biggest diabetes contract yet
Oct. 8, 2019
AngioDynamics buys Eximo to challenge Philips for PAD market, cutting EPS targets
Oct. 4, 2019
Survey finds CMS changes might slow radiation oncology purchases
Oct. 4, 2019
Lantheus strikes deal to buy Progenics, sparking investor backlash
Oct. 3, 2019
IMDRF cybersecurity guidance favors total product life cycle approach
Oct. 3, 2019
Researchers automate EHR analysis for postmarket safety surveillance
Oct. 2, 2019
Stryker inks Conformis deal to develop custom knee surgery instruments
Oct. 2, 2019
Medtronic, Boston Scientific share data on stents with short-course antiplatelet therapy
Sept. 27, 2019
TÜV Rheinland designated as notified body under MDR
Sept. 27, 2019
Boston Scientific and Medtronic devices match on safety in 3-year TAVR trial
Sept. 26, 2019
FDA offers guidance on filing device applications electronically
Sept. 26, 2019
Device makers must adapt to rise of ASCs, analysts say
Sept. 25, 2019
FDA grants breakthrough status to Aurora's concussion treatment
Sept. 25, 2019
FDA tries to spur patient shaping of clinical trial design with draft guidance
Sept. 24, 2019
Active Implants gets FDA breakthrough status for knee implant
Sept. 20, 2019
FDA moves to end need for predicate comparisons in some 510(k)s
Sept. 20, 2019
FDA creates agencywide tech modernization roadmap
Sept. 19, 2019
Adaptive lands deal to provide NGS-based cancer tests to Amgen
Sept. 19, 2019
UK shares 'responsible person' advice as no-deal Brexit looms
Sept. 19, 2019
Analysts tip rise of TAVR to help Teleflex beat growth forecasts
Sept. 18, 2019
TAVR surgical bailout rate fuels talk of relaxing requirements
Sept. 18, 2019
Establishment Labs gets IP boost ahead of pitch for breast implant market
Sept. 17, 2019
Researchers use MRI technique to predict dementia risk
Sept. 13, 2019
FDA clears GE's AI-powered x-ray algorithms for triaging collapsed lungs
Sept. 13, 2019
EU sets out requirements for MDR expert panel members
Sept. 12, 2019
Brexit threatens UK robotic surgery innovation, study finds
Sept. 12, 2019
China exempts certain radiation devices from tariffs, giving boost to Varian
Sept. 12, 2019
Physicians push FDA to shed light on device comparators
Sept. 11, 2019
EBR gets FDA breakthrough tag for wireless cardiac pacing system
Sept. 11, 2019
Doubt cast on value of Exact Sciences' Cologuard
Sept. 10, 2019
Racing Edwards, Abbott starts pivotal trial of tricuspid device
Sept. 6, 2019
FDA floats idea for assessing the risk-benefit profile of weight-loss devices
Sept. 6, 2019
Robotic tech used for cardiac intervention from 20 miles away
Sept. 5, 2019
More Blue Cross plans now covering Senseonics' implantable glucose monitor
Sept. 5, 2019
Prescient gets FDA breakthrough status for colorectal cancer test
Sept. 5, 2019
Biotronik's Orsiro stent beats Abbott's Xience in head-to-head trial
Sept. 4, 2019
Laboratory for Advanced Medicine's liver cancer test gets FDA breakthrough tag
Sept. 4, 2019
Regulators put out call for experts to join device advisory committees
Sept. 2, 2019
McKesson, Philips devices flagged by DHS for cyber vulnerabilities
Aug. 30, 2019
AdvaMed wins some, loses some in FDA guidance on managing uncertainty
Aug. 30, 2019
Surmodics passes milestone in trial of Abbott-licensed paclitaxel-coated balloon
Aug. 29, 2019
Elekta buys ProKnow to boost digital radiotherapy strategy
Aug. 29, 2019
Life Spine talks up global expansion weeks after DOJ hit
Aug. 29, 2019
AtriCure gets expanded FDA label for atrial exclusion device
Aug. 28, 2019
FDA approves pediatric spine device via humanitarian pathway
Aug. 28, 2019
Medicare contractors back use of Inspire's sleep apnea device
Aug. 27, 2019
Heart attack device earns FDA's breakthrough nod
Aug. 23, 2019
Medicare draft decisions may boost Natera, Myriad tests
Aug. 23, 2019
Industry sounds alarm on EU single-use device reprocessing regs
Aug. 22, 2019
FDA scolds diagnostic manufacturer over production practices
Aug. 22, 2019
US task force expands recommended BRCA test population
Aug. 21, 2019
FDA issues device sterilization warning letter
Aug. 21, 2019
Livongo a darling of one Wall Street firm a month after IPO
Aug. 20, 2019
Mercy expands RWE program to capture data from other providers
Aug. 16, 2019
UK plans for express medical products shipping service ahead of Brexit
Aug. 16, 2019
Abbott poised to profit from CMS review of TMVR coverage
Aug. 15, 2019
Industry backs Australia's device identifier plan with caveats
Aug. 15, 2019
Senators push HHS for details of response to DNA test scam
Aug. 15, 2019
Imaging study links poorly controlled blood pressure to marker of cognitive decline
Aug. 14, 2019
'Unprecedented' pricing pressures on Myriad send shares plunging
Aug. 14, 2019
China grants innovative device designation to Novocure's Optune
Aug. 13, 2019
Radiology societies partner with HP on 3D printing registry
Aug. 9, 2019
MD Anderson taps Hitachi for $159M proton therapy expansion
Aug. 9, 2019
Wright Medical rocked by distributor disinterest and staff losses
Aug. 8, 2019
FDA grants breakthrough status to Perfuze stroke device
Aug. 8, 2019
TransEnterix admits its robotics system falls short for docs amid sales slump
Aug. 8, 2019
Healthcare AI funding hits new high as sector matures
Aug. 7, 2019
iCubate lung infection test secures FDA breakthrough status
Aug. 7, 2019
Zimmer hit with $7.7M in damages in hip implant case
Aug. 6, 2019
Japan to reimburse TransEnterix's robotic surgery system
Aug. 2, 2019
UnitedHealthcare's depression test decision boosts Myriad's prospects
Aug. 2, 2019
Cardiac device complications vary 'substantially' by implanting hospital, study finds
Aug. 1, 2019
'Political challenges' drag on Hologic's breast health sales in Latin America
Aug. 1, 2019
DeepMind AI shows potential to accelerate kidney injury diagnosis
Aug. 1, 2019
FDA grants breakthrough status to Procyrion's cardiac device
Aug. 1, 2019
Sports medicine drives Q2 growth at Smith & Nephew
July 31, 2019
FDA clears Lyme disease tests, ending reliance on immunoblots
July 30, 2019
FDA finalizes biliary stent guide after Cook, Boston Scientific feedback
July 26, 2019
Healthcare the lone growth driver for 3M in Q2
July 26, 2019
Consumer genetics dip drives LabCorp Q2 test volumes down
July 25, 2019
DOJ alleges spine maker paid $7M to surgeons in kickbacks
July 25, 2019
Varian raises sales outlook after oncology devices fuel growth
July 25, 2019
FDA directly links Allergan Biocell breast implants with cancer risk, prompting recall
July 24, 2019
Titan Medical warns robotic surgery filing target may slip
July 24, 2019
HHS-backed treatment for mustard gas injuries gains clearance
July 23, 2019
Fertility apps hold promise, but less precise than conventional methods, study finds
July 19, 2019
Teleflex recalls neonatal breathing devices amid gas leak risk
July 18, 2019
BD expedites fixes for faulty pumps after additional injuries
July 18, 2019
Cardinal set to change CEO of struggling medical segment
July 17, 2019
Hospitals may boost outsourcing of lab services: UBS poll
July 17, 2019
Intuitive buys Schölly's robotic endoscope business
July 16, 2019
FDA qualifies tool for nonclinical testing of ultrasound devices
July 12, 2019
PMA approval rate has jumped since FDA changed panel meetings
July 12, 2019
FDA finalizes IDE broadcasting guidance, with concessions to industry
July 11, 2019
FDA hits Clinicon with warning letter over sterility failings
July 11, 2019
Hill-Rom to sell surgical consumables unit for $170M
July 11, 2019
Fitch Solutions tips Roche to challenge Philips for digital pathology market
July 10, 2019
Investment firm downgrades Myriad Genetics as growth thesis weakens
July 10, 2019
UL to close UK medical device notified body operation
July 9, 2019
Invacare lays off 75 as turnaround effort drags on
July 4, 2019
CMS extends ambulatory blood pressure monitoring coverage
July 3, 2019
International Trade Commission probes Intuitive imports following J&J complaint
July 3, 2019
Ruptured Edwards balloons linked to 3 patient deaths
July 2, 2019
Hologic promotes replacement to head diagnostics unit
June 28, 2019
Medtronic insulin pump recall lands in FDA's top risk category after cybersecurity warning
June 28, 2019
OncoCyte delays liquid biopsy test for lung cancer again
June 27, 2019
Anthem adds Teleflex's UroLift to prostate disease coverage
June 27, 2019
FDA finalizes guidance on diagnostic ultrasound systems
June 27, 2019
US medtech market forecast to top $200B by 2023
June 26, 2019
Smartphone heart data mirrors gold standard EKG in study
June 26, 2019
Roche assay identifies Alzheimer's biomarker in blood samples
June 25, 2019
Glaukos strikes deal to buy retinal drug delivery company
June 21, 2019
SEC ends Misonix foreign corruption probe without action
June 21, 2019
Cardiology practice pays $2.5M to settle case involving genetic testing kickback allegations
June 20, 2019
OIG finds Medicare overpaid $125M for radiation services
June 20, 2019
Philips gets FDA approval for over-the-counter defibrillators
June 20, 2019
Swiss notified body to exit sector, heightening EU capacity fears
June 19, 2019
Mount Sinai joins LabCorp to adopt Philips' digital pathology
June 19, 2019
As CMS decision on TAVR looms, a push for broader access
June 18, 2019
Lloyd's exits notified body services, leaving UK with 3
June 14, 2019
DHS warns of severe security flaw with BD infusion pumps
June 14, 2019
AMA adopts measures to shape development, uptake of AI systems in healthcare
June 13, 2019
FDA posts draft guidance on testing of reproductive devices
June 13, 2019
OIG estimates Medicare overpaid $269M for sleep studies
June 13, 2019
China leads world in digital health adoption, Philips survey finds
June 12, 2019
Germany, Ireland push EU to assess device regs preparedness
June 12, 2019
Beta Bionics, Insulet seek shake-up of insulin delivery market at ADA
June 11, 2019
Abbott and Tandem in the spotlight at diabetes meeting
June 7, 2019
Thermo Fisher buys mass spec software partner HighChem
June 7, 2019
Executives expect AI to transform healthcare within 3 years
June 6, 2019
After Varian deal, New York opens 1st proton therapy center
June 6, 2019
FDA approves DT MedTech's total ankle replacement implant
June 6, 2019
House committee passes 6% increase in FDA funding
June 5, 2019
Beckman Coulter buys Cytobank to add data analysis software
June 5, 2019
EMA posts draft guidance on drug-device combinations
June 4, 2019
GS1 updates UDI guideline to reflect changes to FDA position
May 31, 2019
Resolution lands FDA breakthrough nod for liquid biopsy
May 31, 2019
Medtech groups call for immediate action to avoid EU regulatory cliff
May 30, 2019
Philips' 3-year data links drug-coated balloon to sustained benefits
May 30, 2019
Medtronic gets FDA greenlight to expand His-bundle pacing portfolio
May 30, 2019
IMDRF posts guidance on custom-made device exemptions
May 29, 2019
Verily creates machine learning tool to aid diagnostic development
May 29, 2019
FDA approves Novocure device to treat rare lung cancer
May 28, 2019
FDA authorizes Zika test, mulls revoking emergency clearances
May 24, 2019
Faulty platelet counts trigger Class I recall of Beckman Coulter devices
May 24, 2019
Quality failings spur FDA crackdown on 2 defibrillator businesses
May 24, 2019
LifeScan deal challenges Abbott, Dexcom for CGM market
May 23, 2019
Medtronic results build case for renal denervation device
May 23, 2019
Biotronik stent bests Medtronic in study of small-vessel lesions
May 22, 2019
Integra LifeSciences recall draws Class I label from FDA
May 22, 2019
Cook lands rights to sell single-use duodenoscope in US
May 21, 2019
Newly independent Alcon leans on surgical unit while awaiting key product launches
May 17, 2019
FDA classes J&J stapler recall as high risk ahead of advisory panel
May 17, 2019
Physicians call for Digital Health Scorecard to validate products
May 16, 2019
Massachusetts grows medtech exports, but decline in clearances spurs R&D rethink
May 16, 2019
Titan Medical's losses balloon as robotic surgery R&D drive accelerates
May 16, 2019
Medical equipment hit by escalation of US-China trade war
May 15, 2019
FDA extends Abiomed heart pump use to 14 days
May 14, 2019
Philips, Medtronic team up to create image-guided atrial fibrillation device
May 10, 2019
TransEnterix slumps after selling 1 robotic system in Q1
May 10, 2019
BD lowers guidance as FDA paclitaxel alert dents prospects
May 9, 2019
Myriad guidance disappoints investors as pricing pressures dampen expectations
May 9, 2019
FDA grants De Novo to device for cerebral aneurysms
May 9, 2019
FDA finalizes laser guidelines, rebuffing calls for harmonization
May 8, 2019
Verily's nanoparticle diagnostic program evolves into Verve partnership
May 8, 2019
Touchstone Medical Imaging pays $3M to settle HIPAA breach case
May 7, 2019
Medtronic gets FDA approval for wireless pacemaker programmer
May 3, 2019
Abbott gets WHO prequalification for point-of-care HIV test
May 3, 2019
Abiomed misses sales target following 'confusion' caused by FDA letter
May 2, 2019
Tunbridge named interim MHRA medical device chief as Wilkinson retires
May 2, 2019
Smith & Nephew raises outlook as soaring sales in China drive growth
May 2, 2019
DHS highlights cybersecurity weakness in Philips EMR
May 1, 2019
LabCorp weathers PAMA, Quest competition to beat expectations
April 30, 2019
Zimmer Biomet narrowly beats expectations in 'good enough' quarter
April 26, 2019
Manufacturers get finalized guidance from FDA on orthopaedic device material
April 26, 2019
Falling medication delivery sales drag Baxter revenues down again in Q1
April 25, 2019
Sirolimus-eluting balloon wins breakthrough status
April 25, 2019
FDA hits Abaxis with warning letter over changes to assay
April 25, 2019
Playing catch up, Boston Scientific gets FDA approval for Lotus TAVR device
April 24, 2019
Surgical instruments lead organic growth for Stryker in Q1
April 24, 2019
Quest beats analyst Q1 expectations as UnitedHealth drives volume growth
April 23, 2019
Trade groups seek to guide suppliers past pitfalls of new CMS bidding process
April 23, 2019
Intuitive shares tumble as Q1 earnings miss analyst expectations
April 22, 2019
FDA grants breakthrough status to preeclampsia device
April 18, 2019
WHO weighs in on digital health tools in new report
April 18, 2019
Medtronic posts data on stent grafts and venous closure systems
April 18, 2019
Abbott beats guidance in Q1, ramps up full-year earnings forecast
April 17, 2019
EU device group clarifies incoming database requirements
April 16, 2019
Cardiologists push digital health tools as answer to healthcare funding pressures
March 29, 2019
UK provides more no-deal Brexit advice as logjam drags on
March 29, 2019
PwC predicts device makers, pharma to benefit from FDA digital health regulations
March 28, 2019
Neuronetics gets Japanese coverage for antidepressant device
March 28, 2019
Stryker names J&J lawyer as chief legal officer
March 28, 2019
CMS set to reopen controversial cancer test policy
March 27, 2019
CMS pitches new rules for TAVR coverage
March 27, 2019
LifeScan dominates Medicare diabetes test strip market, OIG finds
March 26, 2019
DHS warns of critical cybersecurity weakness with Medtronic implants
March 22, 2019
Key senators demand answers about 'suspect' doctor-device maker ties
March 22, 2019
Illumina-backed study finds limited role for liquid biopsy in lung cancer
March 21, 2019
FDA, NEST detail how extra funding can bolster postmarket safety
March 21, 2019
UK steps up no-deal planning as Brexit clock ticks down
March 21, 2019
Lab industry pushes CMS to withdraw 'highly disruptive' coding changes
March 20, 2019
Abbott gets CE mark for molecular diagnostics machine
March 20, 2019
Analysts tip UnitedHealth's preferred lab network to boost LabCorp, Quest
March 19, 2019
FDA greenlights device for treating carbon monoxide exposure
March 15, 2019
Fresenius gets breakthrough status for hemodialysis software
March 15, 2019
FDA ramps up major CDRH reorg, aiming for 'super office'
March 14, 2019
Durable medical equipment business owner gets prison time for Medicaid fraud
March 14, 2019
HemoSonics gets De Novo nod for POC coagulation device
March 14, 2019
Hill-Rom strikes $180M Voalte takeover to boost connected care unit
March 13, 2019
Omada adds connected blood pressure cuff, glucometer to health program
March 13, 2019
UK to probe safety of paclitaxel cardiovascular devices
March 12, 2019
Philips nabs Carestream unit to boost informatics business
March 8, 2019
Bard pulls mesh implants from EU
March 8, 2019
Low upfront costs fuel investor interest in health app startups, analysts say
March 7, 2019
Tandem suspends software use in pivotal closed loop study to fix bug
March 7, 2019
Medicare panel gives equivocal backing to Novocure's brain cancer device
March 7, 2019
Pharma strikes $220M deal for pain device player Myoscience
March 6, 2019
FDA proposes exempting some flow cytometers from 510(k) requirements
March 6, 2019
Machine learning model aims to match pathologists in IDing lung cancer
March 5, 2019
EU debuts drug-device Q&A ahead of regulatory changes
March 1, 2019
Moody's warns medtech is highly vulnerable to cyberattacks
March 1, 2019
Boston Scientific Lotus matches Medtronic CoreValve in head-to-head TAVR trial
Feb. 28, 2019
Hologic gets EU clearance for breast lesion localization tag
Feb. 28, 2019
UK updates Brexit medtech advice as cliff edge exit looms
Feb. 28, 2019
Introduction of robotic surgery cuts endometrial cancer complications: JAMA
Feb. 27, 2019
Myriad plans companion diagnostic filing as PARP drug clears clinical test
Feb. 27, 2019
Stryker buys Arrinex to expand ENT portfolio
Feb. 26, 2019
FDA rule on device study practices comes into force
Feb. 22, 2019
Japan agrees to reimburse LivaNova's sutureless aortic heart valve
Feb. 22, 2019
Medtronic and J&J lost spine share to pure-play rivals in Q4, analysts say
Feb. 20, 2019
FDA grants breakthrough status to concussion-detecting VR headset
Feb. 20, 2019
Medtronic posts beat-and-raise Q3 despite tumbling heart failure sales
Feb. 19, 2019
Insulet gains 'ACE' label for interoperable insulin pump, following Tandem
Feb. 15, 2019
FDA grants breakthrough status to amyloid beta Alzheimer's test
Feb. 15, 2019
Headwinds stiffen as Quest revenues, earnings miss Q4 estimates
Feb. 14, 2019
Medical devices recalled from US jump in Q4
Feb. 14, 2019
Software products face high-risk upclassing in Australia
Feb. 14, 2019
GenomeDx pays $2M to settle genetic test false claims allegations
Feb. 13, 2019
Industry strikes back at GAO's 'flawed and dangerous' PAMA report
Feb. 13, 2019
FDA approves Orthofix's cervical disc device
Feb. 12, 2019
Precision medical imaging set for explosive growth, analysts say
Feb. 8, 2019
Bigfoot adds Owen Mumford needles to diabetes subscription service
Feb. 8, 2019
Smith & Nephew has Q4 sales miss as headwinds persist
Feb. 7, 2019
LabCorp diagnostics' operating income tumbles as PAMA hits home
Feb. 7, 2019
FDA categorizes Edwards' cardiac diagnostic recall as Class I event
Feb. 7, 2019
Cognoa's autism devices win breakthrough status
Feb. 6, 2019
Current Health's wearable vital sign monitor gets FDA nod
Feb. 6, 2019
FDA warns cardiologists of high mortality in Abiomed post-approval study
Feb. 5, 2019
FDA approves OPKO's point-of-care PSA test
Feb. 1, 2019
Abiomed posts 30% growth on rising heart pump demand
Feb. 1, 2019
Breast health and diagnostics drive Hologic to beat-and-raise quarter
Jan. 31, 2019
Baxter beats estimates despite ongoing medication delivery woes
Jan. 31, 2019
Tumbling breast implant sales drag on Allergan's Q4 results
Jan. 30, 2019
FDA awards breakthrough status to blood test for Alzheimer's risk
Jan. 30, 2019
Philips hits sales targets despite headwinds and patchy performance
Jan. 29, 2019
FDA grants breakthrough status to Liberate's ventilator device
Jan. 25, 2019
Varian begins 2019 with guidance-beating quarter
Jan. 25, 2019
Double-digit growth in hip and knee replacements spikes health spending
Jan. 24, 2019
Duke report identifies barriers to adoption of AI healthcare systems
Jan. 24, 2019
Thermo Fisher expands peanut allergy test menu
Jan. 24, 2019
Abbott misses sales expectations despite device, diagnostic unit growth
Jan. 23, 2019
NESTcc plans pay-for services once FDA funding ends
Jan. 22, 2019
LivaNova highlights studies into efficacy, value of sutureless aortic valve
Jan. 18, 2019
FDA finalizes guidance on development of antimicrobial tests
Jan. 18, 2019
BD, Mercy ally to use clinical data to boost device use
Jan. 17, 2019
Abbott inks Cephea buyout to boost mitral valve pipeline
Jan. 17, 2019
Mayo, Arizona State team up to found medtech startup accelerator
Jan. 17, 2019
After losses to Quest, LabCorp strikes exclusive Texas testing deal
Jan. 16, 2019
Neural network matches cardiologists in EKG analysis study
Jan. 16, 2019
Wound therapy device wins FDA authorization
Jan. 15, 2019
Empatica gets FDA clearance for epilepsy monitor in children
Jan. 11, 2019
NIH researchers develop AI system to improve cervical cancer screening
Jan. 11, 2019
Intuitive ends bumper 2018 with 19% growth in da Vinci procedures
Jan. 10, 2019
FDA denies citizen petition calling for electroconvulsive therapy ban
Jan. 10, 2019
UK updates no-deal Brexit advice as vote on withdrawal agreement nears
Jan. 10, 2019
LabCorp and Quest prepare for year of M&A as price cuts hit small labs
Jan. 9, 2019
CMS issues new DME strategy for patients dually-eligible for Medicare, Medicaid
Jan. 8, 2019
Analysts predict Medtronic will lose ground in booming insulin pump market
Jan. 4, 2019
OIG finds Pacific Medical received unallowable Medicare payments
Jan. 4, 2019
FDA-backed NESTcc set to publish 2019 RWE strategy
Jan. 3, 2019
Engineers tout advance in closed-loop neuromodulation system
Jan. 3, 2019
Boston Scientific strikes $325M Millipede mitral valve repair buyout
Jan. 3, 2019
Edwards gets FDA nod for Sapien 3 Ultra TAVR device
Jan. 2, 2019
FDA reclassifies some electroconvulsive devices in final order
Dec. 23, 2018
NIH study shows C-section mothers half as likely to have stress urinary incontinence
Dec. 20, 2018
Researchers advance 3D-printed, wirelessly-controlled ingestible
Dec. 19, 2018
Novartis, Pear move digital schizophrenia drug into Phase 2
Dec. 18, 2018
Medtech industry cheers as NAFTA 2.0 edges forward
Dec. 14, 2018
FDA adds information on device BLAs to user fee guidance
Dec. 13, 2018
Grand jury indicts physician over alleged medical testing fraud
Dec. 13, 2018
FDA rates GE ventilator safety guard recall as Class I event
Dec. 13, 2018
Australia plans reclassification of medical software to better reflect risk
Dec. 12, 2018
Merck taps Roche for Keytruda companion diagnostic
Dec. 12, 2018
Duodenoscope studies find higher-than-expected contamination rate, FDA says
Dec. 11, 2018
BioSig partners with Mayo Clinic for electrophysiology recording system trial
Dec. 7, 2018
UPenn surgeons perform first robot-assisted bilateral breast reconstruction
Dec. 7, 2018
Pear teases top-line data for opioid use digital therapeutic
Dec. 6, 2018
Edwards expects TAVR demand to fuel double-digit growth in 2019
Dec. 6, 2018
Subtle Medical gets FDA nod for PET-enhancing algorithm
Dec. 6, 2018
FDA classifies Medtronic's ventilator correction a Class I recall
Dec. 5, 2018
OIG finds Medicare overpaid $34M to device suppliers over three years
Dec. 5, 2018
NIH completes enrollment in huge adolescent neuroimaging study
Dec. 4, 2018
GE, VA partner to accelerate creation of 3D medical models
Nov. 30, 2018
Canada vows to strengthen device regulation following media probe
Nov. 30, 2018
BD, Microsoft create software to identify drug diversion
Nov. 29, 2018
NIST takes early step toward bringing photonic chips into healthcare
Nov. 29, 2018
Fighting for market share, LabCorp and Quest plan expansions
Nov. 29, 2018
Metagenomic sequencing shows promise in diagnosing airway infections
Nov. 28, 2018
Synaptive recalls system over brain damage risk
Nov. 28, 2018
FDA approves autoinjector version of Genentech's Actemra
Nov. 27, 2018
Beckman initiates Class I recall of flow cytometers
Nov. 22, 2018
FDA device inspections hit high amid overseas oversight push
Nov. 22, 2018
Sandoz and Pear begin selling digital substance use treatment
Nov. 21, 2018
Boston Scientific snags BTG for $4.2B
Nov. 20, 2018
Colfax strikes $3.15B buyout of orthopaedics player DJO
Nov. 20, 2018
CMS' Verma outlines vision for connected digital health network
Nov. 16, 2018
Philips report identifies barriers to telehealth uptake
Nov. 16, 2018
FDA sounds alarm about off-label drug use in pain pumps
Nov. 15, 2018
ResMed wraps up $750M MatrixCare buyout in SaaS push
Nov. 15, 2018
US Vascular gets FDA warning letter for long-running problems
Nov. 15, 2018
Atlantic gains FDA nod for wearable incontinence device
Nov. 14, 2018
FDA plans to waive informed consent for some clinical trials
Nov. 14, 2018
Medtronic gets CE mark for low-profile thoracic endograft
Nov. 14, 2018
Cardiva's vascular closure system cuts patient recovery times in study
Nov. 13, 2018
Grassley questions FDA about 'troubling' cybersecurity audit
Nov. 13, 2018
FDA clears battery-powered Ebola test for emergency use
Nov. 12, 2018
AliveCor's Apple add-on detects afib at similar rate to costly implant
Nov. 11, 2018
LabCorp loses 2019 Horizon BCBSNJ exclusivity as Quest enters the fray
Nov. 9, 2018
Monteris modifies brain ablation device to counter safety risk
Nov. 9, 2018
Rising Cordis costs drag on Cardinal Health profits
Nov. 8, 2018
BD posts long-awaited clinical data on Lutonix balloon in CLI
Nov. 8, 2018
Shoulder device sales power Wright to beat-and-raise Q3
Nov. 8, 2018
FDA shares open source app for collecting real-world data
Nov. 7, 2018
Disease-detecting AI flounders when applied to images from other hospitals
Nov. 7, 2018
Abbott, J&J take part in FDA's NEST real world evidence pilot
Nov. 6, 2018
Patient deaths following Getinge device shutdowns prompt FDA warning
Nov. 2, 2018
FDA warns about Roche test after reports of patient strokes
Nov. 2, 2018
Zimmer gets FDA nod for knee implant as portfolio strategy advances
Nov. 1, 2018
Moody's boosts growth forecast for US medical device industry
Nov. 1, 2018
23andMe wins FDA clearance for first-of-its-kind genetic test
Nov. 1, 2018
Baxter posts 'frankly disappointing' sales as hurricane aftereffects linger
Oct. 31, 2018
HHS opens cybersecurity coordination center after troubled year
Oct. 31, 2018
Leerink predicts Inspire to clear coverage blockade, quickly grow sleep apnea sales
Oct. 30, 2018
Speedy Medicare breakthrough device coverage plan slated for March
Oct. 26, 2018
ResMed posts double-digit growth as software sales soar
Oct. 26, 2018
Medtronic's dose-controlling app for pain pump gets FDA nod
Oct. 25, 2018
FDA clears Ansh Labs menopausal status test
Oct. 25, 2018
Adverse events prompt FDA to advise monitoring of Alcon implants
Oct. 25, 2018
FDA starts 510(k) pilot to cut optical tomography processing times
Oct. 24, 2018
Medtronic's low-profile thoracic endograft gets FDA nod
Oct. 24, 2018
Myriad's BRCA test supports successful ovarian cancer trial
Oct. 23, 2018
Cardinal credit downgraded after debt-fueled medtech expansion
Oct. 19, 2018
Viseon gets 510(k) clearance for spinal surgery device
Oct. 19, 2018
FDA floats changes to cybersecurity guidance to strengthen safeguards
Oct. 18, 2018
Abbott heart attack test shows early promise in small study
Oct. 18, 2018
Analysts say AI image analysis market to top $2B by 2023
Oct. 18, 2018
Immunodiagnostic demand powers Roche Q3 results
Oct. 17, 2018
Endologix recalls cardiac implants amid ongoing rupture risk
Oct. 16, 2018
FDA warns of Medtronic device cybersecurity risk
Oct. 12, 2018
Cardiology volumes seen boosting medtech companies in Q3
Oct. 12, 2018
Congress expands Sunshine payment reporting rules
Oct. 11, 2018
ICU Medical taps Imprivata for device cybersecurity support
Oct. 11, 2018
TAVR volumes dip in Q3 amid 'aggressive surgeon pushback'
Oct. 11, 2018
Many mastectomy patients later require imaging and biopsies, study finds
Oct. 10, 2018
Stryker pens deals with Synaptive, Ziehm to boost navigation unit
Oct. 10, 2018
RadNet buys Medical Arts to expand New York imaging network
Oct. 9, 2018
Karius posts clinical data on heart infection test
Oct. 5, 2018
UK recalls 58K pregnancy tests after false positive reports
Oct. 5, 2018
Survey exposes lack of understanding of EU device regulations
Oct. 4, 2018
European Parliament passes device-friendly changes to draft HTA law
Oct. 4, 2018
Regulatory professionals working in devices paid far less than pharma peers
Oct. 4, 2018
Medical device companies see upside in NAFTA 2.0
Oct. 3, 2018
US pays 6 times more than Germany for cardiac implants, study finds
Oct. 3, 2018
FDA starts 510(k) pilot in bid to shorten reviews
Oct. 2, 2018
FDA floats changes to Special 510(k) program
Sept. 28, 2018
Butterfly raises $250M in bid to upend ultrasound market
Sept. 28, 2018
FDA reopens comments on decade-old stent guidance
Sept. 27, 2018
FDA reclassifies female condoms to reduce regulatory burden
Sept. 27, 2018
FDA expands use of Baxter bone graft to spinal fusion
Sept. 27, 2018
Premier gets FDA clearance for saliva-based opioid tests
Sept. 26, 2018
Venus to buy Keystone, moving into Boston Sci's TAVR turf
Sept. 26, 2018
FDA approves Cook PAD stent as competition heats up
Sept. 25, 2018
US wins kickback case against clinical lab Calloway
Sept. 21, 2018
Medtronic strikes $1.6B takeover of Mazor Robotics
Sept. 21, 2018
FDA says Florence unlikely to cause critical device shortages
Sept. 20, 2018
Heparin device guidance to cut overdose risk finalized
Sept. 20, 2018
BioSig uplists to small-cap Nasdaq exchange amid cardiac device push
Sept. 20, 2018
MYnd gets breakthrough tag for mental health decision support tool
Sept. 19, 2018
Trimedx to buy Aramark unit in $300M health tech merger
Sept. 19, 2018
Device lobby backs FDA combo product GMP plan
Sept. 18, 2018
AngioDynamics to buy RadiaDyne for radiotherapy devices
Sept. 14, 2018
FDA softens voluntary consensus guidance after industry slams 'devastating' draft
Sept. 14, 2018
House passes bill to amend local Medicare coverage decisions
Sept. 13, 2018
FDA moves to single electronic filings for device submissions
Sept. 13, 2018
J&J buys EIT for 3D-printed titanium spinal implants
Sept. 13, 2018
Medtronic plants hit with FDA warning letters
Sept. 12, 2018
Cook resolves FDA warning letter that slammed quality processes
Sept. 12, 2018
Brigham and Women's installs first neonatal MRI in US
Sept. 11, 2018
Boston Scientific inks $600M Augmenix buyout
Sept. 7, 2018
NIH imaging and bioengineering unit names Bruce Tromberg as director
Sept. 7, 2018
MRI-compatible cardiac rhythm implants cost hospitals $400M a year: report
Sept. 6, 2018
Lilly's tau PET tracer hits goals in late-phase trial
Sept. 6, 2018
Watchdog slams Veterans Health Administration on device sterility
Sept. 6, 2018
FDA adds 1.6M hours to estimate of device labeling burden
Sept. 5, 2018
Aetna to cover Abbott's non-opioid pain implant Proclaim
Sept. 5, 2018
UK sketches medtech future under no Brexit deal
Sept. 4, 2018
NIH awards $3.8M to test fMRI and suicidal thinking
Aug. 30, 2018
Alcon withdraws glaucoma device amid long-term safety concerns
Aug. 30, 2018
Gottlieb hails early breakthrough device successes, plans AI benchmarks
Aug. 30, 2018
NIH-backed trial links device to drop in cardiac arrest deaths
Aug. 29, 2018
IDx publishes AI test data that supported landmark approval
Aug. 29, 2018
Wright Medical inks $435M takeover of implant firm Cartiva
Aug. 28, 2018
HHS calls for feedback on criteria for EHR reporting program
Aug. 24, 2018
Dthera gets FDA breakthrough device status for Alzheimer's digital therapeutic
Aug. 24, 2018
Philips rolls out cardiovascular ultrasound system
Aug. 23, 2018
FDA posts guidance on endpoints in osteoarthritis trials
Aug. 23, 2018
Gynesonics gets FDA nod for fibroid ablation device
Aug. 23, 2018
Australia starts accepting FDA reports in device filings
Aug. 22, 2018
Merck relaunches diabetes management app as map4health
Aug. 22, 2018
Facebook, NYU team up to use AI to accelerate MRI scans
Aug. 21, 2018
FDA details export certificate appeal process in draft guidance
Aug. 17, 2018
FDA OKs quarterly reporting of device malfunction summaries
Aug. 17, 2018
AngioDynamics buys biopsy sealant technology from Surgical Specialties
Aug. 16, 2018
Aetna International pitches vision for interoperable health platform
Aug. 16, 2018
Medtronic starts selling drug-coated balloon in Japan
Aug. 16, 2018
AdvaMed pushes back against FDA humanitarian device guidance
Aug. 15, 2018
With Mylan reeling, Kaléo touts its EpiPen rival for back-to-school season
Aug. 15, 2018
FDA sets out vision to use real-world data in product evaluations
Aug. 14, 2018
TGA seeks industry input on cybersecurity, medtech software guidance
Aug. 10, 2018
Medtronic releases gamification program to improve diabetes outcomes
Aug. 10, 2018
Analysts question mental health app sector's employer-focused strategy
Aug. 9, 2018
FDA warns overreliance on membrane tests could up fetal death risk
Aug. 9, 2018
Boston Scientific inks Veniti takeover to access untapped stent market
Aug. 9, 2018
Regs, patient perceptions threaten to throttle neuromodulation growth
Aug. 8, 2018
Boston Children's expands sequencing of patients with epilepsy, IBD
Aug. 8, 2018
UK regulators reassure medtech sector about Brexit impact
Aug. 7, 2018
BD raises 2018 targets after broad-based Q3 growth
Aug. 3, 2018
Bio-Techne closes $250M Exosome Diagnostics takeover
Aug. 3, 2018
Hologic buys Faxitron for $85M to expand breast cancer business
Aug. 2, 2018
Baxter gets CE mark for Evo IQ smart infusion pump
Aug. 2, 2018
Siemens Healthineers hits Q3 goals as imaging sales rise
Aug. 2, 2018
Currency hit wipes out growth at Fresenius' dialysis device unit
Aug. 1, 2018
Microsoft files patent for eyeglasses-based blood pressure monitor
Aug. 1, 2018
MedTech Europe seeks 'urgent' changes to EU regs deadlines
July 31, 2018
Boston Scientific beats Q2 targets as neuromodulation devices gain share
July 25, 2018
Sanofi Ventures leads $17M Click round to enter digital therapeutics
July 24, 2018
US, China power GE Healthcare to double-digit profit rise
July 20, 2018
LabCorp shuts down IT system after possible hack attack
July 19, 2018
FDA finalizes guidance on use of EHRs in clinical trials
July 19, 2018
Abbott beats expectations as sales of diabetes device soar
July 19, 2018
Ra files for $86M IPO to commercialize vascular disease device
July 18, 2018
FDA approves Stryker flow diverter, creating competition for Medtronic
July 18, 2018
Medtronic gets expanded FDA label for cardiac pacing lead
July 13, 2018
Medtech spared as US unveils tariffs on imports worth $200B
July 13, 2018
EndoGastric Solutions raises $31M to commercialize reflux device
July 12, 2018
Feds pump $24M into development of at-home flu tests
July 12, 2018
Medtronic gets FDA approval for less-invasive LVAD
July 12, 2018
New body to improve patient EHR matching advised by experts
July 11, 2018
Wearable ECG patch increases atrial fibrillation diagnosis in clinical trial
July 11, 2018
US imposes 25% tax on $836M in Chinese medtech imports
July 10, 2018

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