Nick Paul Taylor

1529 articles by Nick Paul Taylor

• Getinge heart support devices join FDA shortage list as raw-materials supply slows production

  Dec. 5, 2022

• Vulnerability of BD’s infusion pumps flagged by 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