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Susan Kelly

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FDA Breakthrough Devices Program nears 300 designations
May 27, 2020
Inari Medical launches IPO, shares take off
May 26, 2020
AdvaMed, health systems set ground rules for return of sales reps
May 20, 2020
Edwards secures CE mark for Pascal tricuspid valve repair device
May 19, 2020
Philips lung ultrasound, Beckman sepsis diagnostic receive BARDA coronavirus backing
May 19, 2020
Medtronic offers 10-year data, pivotal trial update on transcatheter pulmonary valves
May 18, 2020
House Dems carve out $75B for coronavirus testing, contact tracing in bid for new relief package
May 13, 2020
Wright Medical sales miss consensus as lower extremities business drags
May 12, 2020
AtriCure treatment for persistent AFib shows superiority in study
May 11, 2020
Guardant offers 'encouraging' colorectal cancer screening update, as analysts await further data
May 6, 2020
Oncology systems maker Varian ekes out sales gain amid procedure delays
May 5, 2020
Ventilator sharing among states critical to save COVID-19 patient lives: Health Affairs paper
May 4, 2020
Hologic to launch 2nd coronavirus test amid broader sales slide
April 30, 2020
FDA says 18 deaths linked to intragastric weight loss balloons
April 28, 2020
FDA encourages remote review of digital pathology slides amid COVID-19
April 27, 2020
Edwards sees 14% sales bump in Q1, but near-term TAVR prospects grim
April 24, 2020
FDA finalizes post-inspection feedback protocol for medical device makers
April 22, 2020
As COVID-19 antibody tests proliferate, analysts see market worth billions for Abbott, Roche and others
April 21, 2020
CMS, surgeons group offer paths forward to resume elective procedures
April 20, 2020
Device to wean COVID-19 patients off ventilators gains EUA
April 15, 2020
CMS removes ventilators from DME bidding program due to high coronavirus demand
April 14, 2020
J&J, Takeda cancel $400M surgical patch deal after antitrust scrutiny
April 13, 2020
FDA EUAs go to 1st blood purifiers for COVID-19 patients, new N95 sterilizers
April 13, 2020
OraSure wins BARDA contract for in-home coronavirus self-test
April 8, 2020
Study questions TAVR access disparities under new CMS coverage policy
April 7, 2020
FDA allows for infusion pump modifications to prevent shortages
April 6, 2020
BD rolls out test to detect coronavirus antibodies
April 1, 2020
FDA flags Class I recall of Medtronic brain stent, citing fracture reports
March 31, 2020
Medtronic's renal denervation system shows it can lower blood pressure
March 30, 2020
Medtech industry asks for FEMA's help allocating ventilators to frontlines
March 25, 2020
Senseonics halts new CGM sales, pulls 2020 guidance
March 23, 2020
FDA greenlights expanded remote patient monitoring to keep patients out of coronavirus-slammed hospitals
March 20, 2020
Moody's cuts medtech outlook on coronavirus upheaval
March 18, 2020
Endologix secures FDA approval for new abdominal stent graft
March 17, 2020
Value-based payment models take hold in medtech, but barriers slow shift
March 16, 2020
Rival to Boston Scientific device used in TAVR wins CE mark
March 11, 2020
FDA updates guidance on 510(k) submissions for electrosurgical devices
March 10, 2020
TMS pioneer Neuronetics gets breakthrough nod, CEO departs
March 9, 2020
Some pacemakers, EKGs, diabetes devices may face newly flagged Bluetooth cyber risk
March 4, 2020
Livongo tops Q4 estimates with contributions outside of diabetes
March 3, 2020
FDA seeks 'right balance' as it permits immediate use of coronavirus tests
March 2, 2020
FDA advises boxed warning for surgical devices half-decade after flagging cancer risk to women
Feb. 26, 2020
Analysis casts doubt on Boston Scientific TAVR embolic protection device
Feb. 25, 2020
On FDA's agenda: ortho reclassifications, cancer tests, AI in imaging
Feb. 24, 2020
Battle of the 'bots: 4 robotic surgery rivalries to watch in the year ahead
Feb. 24, 2020
FDA deems Abbott Vascular, ResMed, Teleflex recalls high risk
Feb. 20, 2020
As CMS coverage decision nears, Abbott gears for MitraClip expansion
Feb. 18, 2020
Wearable heart rate sensor accuracy didn't vary across skin tones in small Duke study
Feb. 11, 2020
Medtronic faces key test in establishing US market for renal denervation
Feb. 10, 2020
Contura nabs FDA nod for female incontinence device
Feb. 4, 2020
Its DOJ case settled, ResMed tops revenue expectations in Q2
Feb. 3, 2020
FDA clears Eko's stethoscope algorithms for AFib, heart murmur screening
Jan. 29, 2020
FDA OKs latest Medtronic leadless pacemaker, potentially tripling market
Jan. 22, 2020
UK health authority 'proactively' monitoring breast implant illness reports
Jan. 21, 2020
Amid Q4 letdown, Boston Scientific aims for $1B mark in structural heart
Jan. 15, 2020
Robotic surgeries surge to 15% of all procedures, despite limited evidence
Jan. 14, 2020
FDA guidance on catheters zeros in on testing, coatings
Jan. 13, 2020
Enrollment has ended in Essure postmarket study, FDA says
Jan. 13, 2020
FDA OKs alternative to open heart surgery for Abbott's HeartMate 3 pump
Jan. 8, 2020
EU group offers guidance on meeting MDR's cybersecurity standards
Jan. 7, 2020
Terumo subsidiary gains FDA nod for aneurysm flow diverter
Jan. 6, 2020
Simplified devices, pharmacy access among 2020 catalysts for diabetes tech: analysts
Jan. 6, 2020
FDA finalizes exemptions for certain devices from 510(k) review
Dec. 31, 2019
Medtech manufacturing lags pharma in emerging markets, McKinsey report says
Dec. 23, 2019
LivaNova recalls vagus nerve implant amid reset problems
Dec. 23, 2019
FDA downclassifies cranial electrotherapy stimulators for anxiety, insomnia
Dec. 20, 2019
AI-based heart failure screening from Eko, Mayo Clinic earns FDA breakthrough nod
Dec. 19, 2019
FDA warns Conformis over sterilization cycle failures
Dec. 19, 2019
Telehealth provider Ro to offer De Novo-winning obesity capsule
Dec. 18, 2019
FDA may change how it announces PMA, HDE decisions
Dec. 17, 2019
Dexcom CEO on remote monitoring outage: 'No excuses. We can do better'
Dec. 16, 2019
FDA moves to electronic premarket submissions
Dec. 16, 2019
FDA names Beta Bionics' pancreas tech a breakthrough device
Dec. 11, 2019
Abbott warns of issues with HeartMate 3 cable, mobile power unit
Dec. 10, 2019
House bill would speed CMS coverage for breakthrough medtech
Dec. 9, 2019
FDA proposes alternative 510(k) criteria for MRI coils
Dec. 9, 2019
Company of the Year: Edwards Lifesciences
Dec. 9, 2019
Sens. Wyden, Booker push CMS, FTC, insurers on bias in algorithms
Dec. 4, 2019
Feds charge lab owner in latest genetic testing kickback scheme
Dec. 2, 2019
FDA seeks public input on pediatric device applications including ways to minimize burden
Dec. 2, 2019
GE Healthcare bulks up in 3D printing, robotics, patient monitoring
Dec. 2, 2019
Boston Heart to pay $26.7M to settle alleged doctor kickback scheme
Nov. 27, 2019
Standards body urged to add device identifiers to insurance claims forms
Nov. 26, 2019
Medical devices are bigger culprit in antibiotic-resistant infections than surgical procedures: CDC analysis
Nov. 25, 2019
FDA flags 2 more deaths, over 60 device failures tied to heart balloon pump
Nov. 20, 2019
FDA approves 1st contact lens to slow myopia in children
Nov. 19, 2019
Edwards recalls Pascal valve guide sheath in Europe amid potential for embolizations
Nov. 18, 2019
Qiagen in talks with potential buyers amid weak results, restructuring
Nov. 18, 2019
Nascent digital therapeutics group defines best practices, ethics code
Nov. 13, 2019
Medtronic's Micra AV pacemaker meets study goals, submitted for FDA review
Nov. 12, 2019
Wright Medical growth slowed in run-up to Stryker deal
Nov. 11, 2019
Medtronic, Boston issue paclitaxel data in rebuff to safety worries
Nov. 6, 2019
As Essure implant return deadline nears, FDA study enrollment inches up
Nov. 5, 2019
5 breakthrough devices qualify under finalized faster outpatient payment path
Nov. 4, 2019
Medtronic developing fully implanted LVAD with FDA breakthrough support
Oct. 30, 2019
FDA again warns of leak risk with Endologix AAA grafts
Oct. 29, 2019
Abiomed says right-heart pump protocol boosts survival in postmarket data
Oct. 28, 2019
TAVR momentum lifts Edwards' Q3 results, beating estimates
Oct. 24, 2019
FDA expands MDIC quality pilot to non-compliant manufacturers
Oct. 22, 2019
Sleep apnea testing shifts to the home, survey suggests
Oct. 21, 2019
Medtronic rolls out AI-assisted colonoscopy system in Europe
Oct. 21, 2019
FDA warns dental X-ray supplier over radiation exposure reporting
Oct. 16, 2019
California bill to end excessive dialysis profits becomes law
Oct. 15, 2019
Smartphone health coaching gets some people moving, study says
Oct. 14, 2019
FDA pushes back against criticism of third party 510(k) review
Oct. 14, 2019
Medtronic recalls more than 100K guide catheters for fragment risk
Oct. 9, 2019
Teleflex recalls GaleMed infant breathing device it distributed
Oct. 9, 2019
From robots to staplers, a top 10 list of medtech safety hazards
Oct. 8, 2019
Abbott pulling ahead in glucose monitoring race: UBS doc survey
Oct. 7, 2019
Mechanical thrombectomy market poised to double: analysts
Oct. 7, 2019
Venture capital investing in digital health cools in Q3: report
Oct. 2, 2019
Third-party software vulnerability could endanger medical devices, FDA and DHS warn
Oct. 2, 2019
Robotics, navigation systems create buzz at spine meeting
Oct. 1, 2019
Edwards shows improved quality of life, durability of TAVR systems in trio of studies
Sept. 30, 2019
Abbott's MitraClip outperforms medical therapy in study at 3 years
Sept. 30, 2019
Medtronic plans to answer da Vinci with rival soft tissue robot
Sept. 25, 2019
Medtronic updates Evolut TAVR system, gains FDA nod
Sept. 23, 2019
FDA lays out vision for device conformity testing pilot
Sept. 23, 2019
Manufacturer modifies wheelchair for off-roading, draws FDA warning
Sept. 18, 2019
Wright Medical's Cartiva woes will take time to fix: analysts
Sept. 17, 2019
Chronic bronchitis device wins breakthrough designation
Sept. 17, 2019
Zimmer Biomet's Rosa Brain recall categorized as Class I
Sept. 17, 2019
Varian buys software developer for AI cancer work
Sept. 16, 2019
Nurses, physician assistants rarely interpret diagnostic images, study finds
Sept. 16, 2019
FDA finalizes 4 guidances to clarify 510(k) pathways
Sept. 13, 2019
Baxter puts up $230M for noninvasive fluid monitor company
Sept. 11, 2019
Abbott says AI technology can help diagnose heart attacks
Sept. 11, 2019
Medtronic MiniMed insulin pump gains German reimbursement
Sept. 10, 2019
Zimmer gets 510(k) clearance for Persona Revision knee
Sept. 10, 2019
Hospital buying data point to TAVR surge in Q3: analysts
Sept. 9, 2019
Pulmonary arterial hypertension device wins FDA breakthrough designation
Sept. 9, 2019
FDA finalizes guidance for accepting De Novo requests
Sept. 9, 2019
FDA finalizes guidance on HDEs after AdvaMed scrutiny
Sept. 6, 2019
Tool to bust coronary plaque with sonic waves wins FDA breakthrough nod
Sept. 4, 2019
Imaging test usage is reaccelerating, JAMA study finds
Sept. 4, 2019
Conformis sues Zimmer Biomet over patent infringement
Aug. 20, 2019
Fusion-less scoliosis device from Zimmer Biomet earns HDE
Aug. 19, 2019
FDA approves neuromodulation device for heart failure
Aug. 19, 2019
V-Wave gets 2nd breakthrough designation for interatrial shunt
Aug. 16, 2019
FDA hits medicine cabinet and cart maker Talon with warning letter
Aug. 14, 2019
Analysts predict big jump in continuous glucose monitor use
Aug. 14, 2019
Stryker acquires maker of device sterilization systems
Aug. 13, 2019
Australia weighs in on paclitaxel-coated balloons
Aug. 13, 2019
Blood test to detect breast cancer recurrence, guide treatment, shows promise in small study
Aug. 12, 2019
Ambu to pay $3.3M to settle False Claims Act allegations
Aug. 12, 2019
NuVasive looks to tech pipeline, overseas expansion in bid for spine market share
Aug. 12, 2019
UBS surgeon poll points to neuromodulation market slowdown
Aug. 9, 2019
Guardant Q2 sales soar on liquid biopsy adoption
Aug. 7, 2019
Abbott recommends removal of certain ICDs due to exposed wires
Aug. 6, 2019
BD: FDA says Lutonix paclitaxel balloon not approvable for below the knee
Aug. 6, 2019
VA software workarounds put patient data at risk: OIG
Aug. 5, 2019
B. Braun gets breakthrough status for paclitaxel-coated balloon catheter
Aug. 5, 2019
FDA extends comment period for draft guidance on magnetic resonance safety
Aug. 5, 2019
FDA announces fiscal 2020 device user fee rates
July 31, 2019
Slow spine market growth to persist as insurers push back, UBS survey suggests
July 31, 2019
Mayo, Boston Scientific deepen ties with medtech accelerator launch
July 30, 2019
Humana accuses Abbott of duping it to pay to remove dodgy heart devices
July 30, 2019
ResMed discloses tentative DOJ settlement, sets aside $41.2M
July 29, 2019
Australia on watch for possible EU notified body shortage
July 29, 2019
New delivery system for sinus stent gains FDA approval
July 29, 2019
Stryker says Mako robot driving orthopaedic share gains
July 26, 2019
PCORI, MD Anderson team up on lung cancer screening aid
July 24, 2019
Walgreens adds Dexcom, Propeller to digital marketplace
July 24, 2019
FDA grants first cochlear implant indication for asymmetric hearing loss
July 23, 2019
FDA sets final guidance on combo product safety reporting
July 23, 2019
HER2 breast cancer imaging tech gets breakthrough nod
July 22, 2019
Random plasma glucose testing helps predict diabetes in large VA study
July 22, 2019
Burst balloons prompt safety alert on Edwards Sapien 3 Ultra valve system
July 22, 2019
Most hospitals don't meet watchdog group's safe volume thresholds for high-risk surgeries
July 18, 2019
FDA warns of risks when shunt implants, hearing devices mix
July 17, 2019
Abbott's latest MitraClip version gains FDA approval
July 16, 2019
Bayer MRI contrast agent gets nod for coronary artery disease
July 16, 2019
GE recalls infant warmers due to panel, latch cracks
July 15, 2019
Ventilator software error prompts Hamilton Medical recall
July 15, 2019
Screenings fail to explain rise in colorectal cancer in younger adults, study finds
July 15, 2019
CRT wheelchair protection passes House Energy & Commerce Committee
July 12, 2019
Edwards poised for a Q2 TAVR rebound, analysts predict
July 10, 2019
WHO expands lists of essential in vitro diagnostics
July 10, 2019
Medtronic HVAD shows low stroke risk in study of thoracotomy approach
July 9, 2019
Feds warn of cyber vulnerability in hospital anesthesia machines
July 9, 2019
Edwards issues safety notice for Centera valve after reports of injury, death
July 8, 2019
Insulin pen smart cap maker in talks to supply Sanofi
July 8, 2019
Spanish agency steps up to become an MDR notified body
July 8, 2019
Wright Medical shares tumble amid report of Cartiva slowdown
July 3, 2019
FDA patient advisory meeting set to tackle cybersecurity in devices
July 3, 2019
As digital health investing matures, report says sector dodges a bubble
July 2, 2019
FDA responds to feedback on De Novo classification requests
July 2, 2019
Military-focused abdominal trauma foam earns FDA breakthrough status
July 1, 2019
House lawmakers introduce bill to delay PAMA data collection
July 1, 2019
Boston Scientific says Watchman more cost effective than drugs for AFib
July 1, 2019
Interagency workshop to focus on device interoperability
June 28, 2019
Jejunostomy tube manufacturer draws FDA warning letter
June 26, 2019
FDA offers guidance on data for prostate ablation devices
June 26, 2019
MRI as safe as cardiac catheterization for coronary disease screening: NEJM
June 25, 2019
Mayo Clinic to build proton therapy facility on Florida campus
June 25, 2019
Hologic moves to acquire French ultrasound company
June 24, 2019
Teleflex recalls more endotracheal tubes, now linked to four deaths
June 24, 2019
Final TAVR Medicare decision gets thumbs up from Edwards, Medtronic
June 24, 2019
NIH's Collins highlights progress on 3D printed human organs
June 21, 2019
Bursting balloon catheters prompt Cook Medical recall
June 19, 2019
Foam to stop abdominal bleeding gets FDA breakthrough nod
June 19, 2019
FDA approves cochlear implant designed for MRI
June 18, 2019
Bio-Techne gains breakthrough status for liquid biopsy prostate test
June 18, 2019
FDA 'white hat' hacking tools may combat medical misinformation
June 17, 2019
Health Canada seeks advice on device action plan next steps
June 17, 2019
SaMD will increase device innovation: Fitch
June 17, 2019
Many in need of knee cartilage repair excluded from studies, researchers say
June 14, 2019
Antibiotic resistance test for gonorrhea gets FDA breakthrough nod
June 12, 2019
Inhaler monitoring lowers COPD hospitalizations in small study
June 12, 2019
EU names UDI issuers in move to new medtech regs
June 11, 2019
Pathology group sets expectations for DTC genetic tests
June 11, 2019
Stimulation device for IBS pain in children gains De Novo clearance
June 10, 2019
Medtech avoids tariff blow as US, Mexico reach deal
June 10, 2019
Harvard's Wyss Institute receives $131M gift
June 10, 2019
Concussion test gets breakthrough nod in fast-growing field
June 7, 2019
Apple Watch, mesh slings among new NESTcc projects
June 5, 2019
Muscle relaxation app helps calm migraine in small NYU study
June 5, 2019
Donor lung preservation system gains expanded indication
June 4, 2019
OIG issues alert on genetic testing scam
June 4, 2019
Multi-cancer blood test shows early promise at ASCO
June 3, 2019
Device makers could feel pinch from Mexico tariffs
June 3, 2019
Roche, GE Healthcare partner on software for tumor boards
June 3, 2019
Wearable glucose monitor wins CE mark, as market gets crowded
May 31, 2019
Test for Parkinson's wins FDA breakthrough designation
May 29, 2019
Qiagen launches companion test for Novartis breast cancer treatment
May 29, 2019
Neurostimulators could be good match for stroke patients, study suggests
May 28, 2019
FDA clears endoscope connector to prevent fluid backflow
May 28, 2019
Neuromodulation patch for migraine gains De Novo nod
May 28, 2019
Extragenital tests for chlamydia and gonorrhea get FDA nod
May 24, 2019
FDA on Abiomed right heart device: patient selection is key
May 22, 2019
Abbott releases 30-day data on tricuspid valve repair system
May 22, 2019
Stryker wins approval for brain aneurysm stent system
May 21, 2019
J&J's Auris unveils early results on Monarch robot for lung procedures
May 21, 2019
FDA warns diabetes patients against use of unauthorized devices
May 20, 2019
Philadelphia jury awards $80M in J&J pelvic mesh suit
May 20, 2019
Ra Medical files suit alleging rival interfered with IPO
May 20, 2019
Canada raises medical device regulatory fees
May 17, 2019
Abbott, NIH collaborate on neuroscience research
May 15, 2019
Haemonetics sells plant, gains expanded indication for blood analyzer systems
May 15, 2019
CMS will weigh broader mitral valve repair NCD, analysts predict
May 14, 2019
Same-day upper and lower endoscopies improve care, costs: JAMA
May 14, 2019
Medtronic, Boston Scientific unveil ICD data
May 13, 2019
LabCorp to sell Qiagen companion diagnostic for bladder cancer
May 13, 2019
Medicare contractors finalize narrow coverage for glioblastoma treatment
May 13, 2019
Eye scan to detect Alzheimer's biomarker gets breakthrough status
May 10, 2019
FDA warns of rapid battery draining in some Medtronic pacemakers
May 8, 2019
FDA updates imaging rules in final guidance
May 8, 2019
Test for circulating tumor DNA wins FDA breakthrough designation
May 7, 2019
FDA issues final guide on device submission meetings, feedback
May 7, 2019
Test for gene fusions in tumors gains breakthrough status
May 6, 2019
FDA OKs Staar Surgical clinical study initiation after PMA supplement holdup
May 6, 2019
EU issues device, diagnostics database requirements
May 6, 2019
AI diagnostic tool for kidney disease earns breakthrough status
May 3, 2019
CMS approves Livongo as Medicare Advantage provider
May 1, 2019
Plastic surgery device maker draws FDA warning letter
May 1, 2019
Device to preserve donor lungs wins FDA approval
April 30, 2019
CMS reopens coverage determination on next generation sequencing for cancer patients
April 30, 2019
UK issues alert on risks with J&J surgical stapler
April 29, 2019
Edwards recalls two heart catheters used in infants
April 29, 2019
Cardiology groups oppose CMS policy shift on TAVR volume
April 29, 2019
FDA publishes guidance on device performance bench tests
April 26, 2019
FDA pitches stronger controls, new labeling for surgical staplers
April 24, 2019
Edwards Lifesciences beats profit forecasts amid low-risk TAVR momentum
April 24, 2019
Study supports genetic testing for sudden cardiac arrest
April 23, 2019
Obesity device to slow stomach emptying gets approval
April 23, 2019
More patients die after starting dialysis than registry suggests: Harvard study
April 23, 2019
FDA wants details on nitinol in premarket device applications
April 22, 2019
FDA drafts premarket recommendations for quantitative medical imaging
April 22, 2019
CDC rule removes barrier to sale of escape respirators
April 22, 2019
Brainlab recalls spine 3D navigation software for incorrect display
April 17, 2019
AI poised to 'transform' medical imaging, radiology society says
April 17, 2019
FDA approves post-angioplasty dissection repair device
April 16, 2019
Edible hydrogel capsule to treat obesity gets FDA go-ahead
April 16, 2019
Contaminated duodenoscopes linked to 3 new deaths, 45 more infections, FDA says
April 15, 2019
FDA flags breathing tube shortage tied to sterilization plant closing
April 15, 2019
AliveCor's AI software for EKG rhythms gets market OK
April 15, 2019
Avinger's image-guided device for PAD gets FDA nod
April 11, 2019
Prices soar for new medtech, but payment lags: report
April 10, 2019
Pfizer, Concerto collaborate on AI in precision oncology
April 10, 2019
FDA warns patients to steer clear of pre-owned test strips
April 9, 2019
Medtronic, Blue Cross strike value-based pact for glucose monitors
April 9, 2019
Abiomed reports improved survival rates in cardiogenic shock patients
April 8, 2019
Nvidia, American College of Radiology partner on AI platform
April 8, 2019
Medtronic analysis tracks reduced strokes in HVAD patients
April 8, 2019
Saturated oxygen treatment for heart attack wins FDA approval
April 5, 2019
Disposable spinal rod strain sensor earns De Novo clearance
April 3, 2019
FDA greenlights study of breakthrough device to treat aggressive pancreatic cancer
April 3, 2019
Channel Medsystems' endometrial cryoablation device gets FDA nod
April 2, 2019
FDA gives PMA to injection treatment for knee pain
April 2, 2019
FDA repeals some regs on radiation-emitting devices
April 1, 2019
CMS to tackle lab payments codes in pair of public meetings
April 1, 2019
FDA finalizes rules for anthrax bacteria tests, spine devices
April 1, 2019
ECRI Institute launching international device testing lab
March 29, 2019
Sterilizer plant shutdown prompts FDA action on device shortages
March 27, 2019
FDA clears Zimmer robot that combines brain, spine, knee functionality
March 27, 2019
CMS greenlights LivaNova's protocol for depression device trial
March 26, 2019
CMS due to release updated TAVR coverage determination
March 26, 2019
Biomagnetic imaging for chest pain wins FDA clearance
March 25, 2019
Not even money prods patients to mail-in colon tests, study suggests
March 25, 2019
EU device group wants clarity on expert panels under MDR
March 25, 2019
FDA approves first-of-its-kind heart failure device
March 22, 2019
Alzheimer's device De Novo on the line at FDA panel
March 20, 2019
FDA warns Sientra, J&J's Mentor on lax post-approval breast implant studies
March 20, 2019
BD wins PMA for stent treating venous occlusive disease
March 19, 2019
FDA outlines new device priorities in budget justification report
March 19, 2019
FDA: Avoid paclitaxel-coated PAD devices for most patients
March 18, 2019
TAVR called 'game changing' in studies of low-risk patients
March 18, 2019
Intuitive's da Vinci SP gets FDA otolaryngology clearance
March 18, 2019
Abbott gains expanded indication for MitraClip valve repair device
March 15, 2019
FDA qualifies test for traumatic brain injury
March 13, 2019
Smith & Nephew buys skin substitute maker for $660M
March 13, 2019
Intrathecal drug delivery system wins FDA breakthrough designation
March 12, 2019
Edwards deepens structural heart position with new investments
March 12, 2019
FDA flags surgical stapler risks, plans advisory meeting
March 11, 2019
TAVR for low-risk patients in spotlight at ACC
March 11, 2019
AdvaMed raises concerns with FDA's proposed De Novo model
March 11, 2019
AI tool for cancer diagnosis wins FDA breakthrough status
March 8, 2019
Ascension hospital network taps Abbott diagnostics for lab work
March 6, 2019
Device to detect internal bleeding wins De Novo clearance
March 5, 2019
Masimo brain monitor gets CE mark pediatric indication
March 5, 2019
Blood test identifies proteins to predict preterm birth
March 4, 2019
Medtronic says corrected IN.PACT analysis to be published in JACC
March 4, 2019
Scientists propose universal standard to calibrate CT scanners
March 4, 2019
Gene test for antibiotic resistance gets FDA breakthrough nod
March 1, 2019
Medtronic Resolute stent gains expanded indication
Feb. 27, 2019
Thermo Fisher lung cancer test wins expanded approval in Japan
Feb. 27, 2019
FDA warns breast infrared imaging tool should not replace mammography
Feb. 26, 2019
Verily launches eye disease screening algorithm in India
Feb. 26, 2019
Swiss regulator weighs in on textured breast implants
Feb. 20, 2019
Intuitive gains FDA clearance for Ion lung catheter
Feb. 20, 2019
FDA proposes new channel for giving feedback on inspections
Feb. 19, 2019
FDA clarifies pathway for devices used in regenerative medicine
Feb. 19, 2019
Medtronic recalls pacemakers due to software error
Feb. 19, 2019
FDA orders doctor to stop marketing unapproved breast augmentation device
Feb. 15, 2019
Breast implants face increased safety scrutiny in Canada
Feb. 13, 2019
Edwards Lifesciences buys maker of brain oxygen monitor
Feb. 13, 2019
Rapid test for brain injury gets FDA breakthrough status
Feb. 12, 2019
Device to prevent spinal disc herniation wins PMA after setback
Feb. 12, 2019
Device that extracts brain tumors gains FDA breakthrough status
Feb. 11, 2019
FDA finalizes guidance to strengthen its recall processes
Feb. 11, 2019
Mayo, Intermountain set partnerships for new tech hubs
Feb. 11, 2019
Teleflex granted FDA approval for vascular closure device
Feb. 6, 2019
BD results largely expected, beats on revenue
Feb. 5, 2019
Healthcare groups urge CMS to keep coverage of NGS cancer tests
Feb. 5, 2019
Cook Medical aortic dissection device gets FDA approval
Feb. 5, 2019
Oxipit AI-based tool for chest X-ray analysis gets CE mark
Feb. 4, 2019
FDA announces warfarin test strips, IV fluid transfer systems recalls
Feb. 4, 2019
Stryker issues voluntary field action after 6 deaths linked to defibrillator bug
Feb. 4, 2019
Edwards' sales on track, but outlook cautious
Feb. 1, 2019
Cybersecurity device plan seeks alignment of industry, regulators
Jan. 30, 2019
Stryker impresses in Q4, sets bold forecasts
Jan. 30, 2019
J&J data suggests its stapler reduces more lung surgery air leaks than competitor
Jan. 29, 2019
FDA sets March date for breast implant panel meeting
Jan. 29, 2019
Draeger Medical recalls single-use breathing circuits
Jan. 28, 2019
ResMed Q2 revenue miss sends shares plunging
Jan. 28, 2019
Zimmer Biomet gets 510(k) for robotic knee surgery system
Jan. 28, 2019
Intuitive Surgical to step up investment outside the US
Jan. 25, 2019
Medtronic data show no paclitaxel-mortality link amid FDA warnings
Jan. 23, 2019
Illumina TruSight assay gets FDA breakthrough designation
Jan. 23, 2019
M&A, robotics among medtech growth drivers for 2019: Moody's
Jan. 22, 2019
Verily Study Watch gets FDA nod for EKG
Jan. 22, 2019
Bigfoot could shake up insulin delivery market, analyst says
Jan. 22, 2019
FDA flags mortality risk of paclitaxel with stents, balloons for PAD
Jan. 18, 2019
FDA clears energy tools for TransEnterix robotic surgery system
Jan. 16, 2019
Medtronic links patients' pacemakers with their smartphones
Jan. 16, 2019
Abbott heart device for premature babies wins FDA approval
Jan. 15, 2019
FDA clears absorbable foot and ankle implant
Jan. 15, 2019
Jefferies predicts upbeat 2019 medtech outlook
Jan. 14, 2019
Mobile and wearable data increasingly useful to patients, JAMA authors say
Jan. 14, 2019
FDA grants breakthrough designation to wearable dialysis device
Jan. 14, 2019
FDA to beef up Sentinel postmarket electronic safety system
Jan. 11, 2019
Medical records key to Apple health strategy: report
Jan. 9, 2019
Medtronic recalls imaging software used in brain surgery
Jan. 9, 2019
Hologic boosts its first-quarter revenue outlook
Jan. 8, 2019
TransEnterix forecasts revenue growth, sells more robots
Jan. 8, 2019
Endologix recalls Nellix aneurysm sealing system
Jan. 7, 2019
AI with EKG can detect a form of heart disease, research shows
Jan. 7, 2019
Hospitals gain leverage on medical device pricing: report
Jan. 7, 2019
LabCorp inks licensing pact for Genfit liver test
Jan. 4, 2019
CMS sets user fee increase for CLIA-certified labs
Dec. 31, 2018
GAO: DME supplier pool shrinks under competitive bidding
Dec. 26, 2018
Health Canada unveils plan to improve medical device safety
Dec. 21, 2018
UK regulator puts brakes on Thermo Fisher-Gatan deal
Dec. 20, 2018
Aortic stent graft market on path to solid growth
Dec. 19, 2018
Cardiva wins FDA approval for its vascular closure system
Dec. 19, 2018
Medtronic wins FDA OK for InterStim smart programmer
Dec. 18, 2018
OIG: Medicare contractor overpaid hospitals for radiation treatments
Dec. 18, 2018
FDA addresses manufacturing site changes in final guidance
Dec. 17, 2018
FDA draft guidance aims to clarify X-ray radiation rules
Dec. 17, 2018
Nonprofit gets boost to realize automated insulin delivery app
Dec. 17, 2018
Rapid diagnostic test detects Ebola, malaria in the field
Dec. 14, 2018
UK readies 'worst-case' Brexit plan for medical devices
Dec. 12, 2018
HIMSS: Health coaching could boost value of wearables
Dec. 12, 2018
Thermo Fisher gets FDA nod for plazomicin immunoassay
Dec. 11, 2018
Hologic begins selling 3-in-1 uterine scope
Dec. 11, 2018
Cybersecurity priorities laid out by key House panel
Dec. 10, 2018
FDA clears Contego Medical peripheral angioplasty system
Dec. 10, 2018
FDA to revisit transvaginal mesh issues at February meeting
Dec. 10, 2018
Device industry 2019 outlook beats hospitals, pharma: Moody's
Dec. 7, 2018
ResMed buys maker of COPD, asthma monitoring platform
Dec. 5, 2018
FDA endorses open database for genetic variants
Dec. 5, 2018
Medtronic AFib study combines hot, cold ablation techniques
Dec. 4, 2018
Medtech R&D adapting under new pressures, industry study shows
Dec. 4, 2018
Medicare could overpay billions for lab tests: GAO
Dec. 3, 2018
FDA OKs first test to detect herpes in newborns
Dec. 3, 2018
LabCorp cuts its profit outlook, citing volume shortfall
Dec. 3, 2018
FDA issues draft guidance on blood glucose monitors
Nov. 30, 2018
Zimmer Biomet recalls spine fusion, bone growth stimulators
Nov. 28, 2018
Quest closes buy of Midwest lab services business
Nov. 28, 2018
Reprocessor receives FDA clearance for 4 catheters
Nov. 27, 2018
Pacing leads recalled for potential connector separation
Nov. 27, 2018
Medtronic buys nutrition data startup for diabetes care
Nov. 26, 2018
FDA details ramp-up of postmarket device oversight
Nov. 21, 2018
Scientists unveil first 3D images from new whole-body scanner
Nov. 21, 2018
Medtronic posts strong Q2 on diabetes, pain management
Nov. 20, 2018
New Philips ventilator combines two modes in one device
Nov. 20, 2018
FDA plan would ease regulations for prescription drug apps
Nov. 20, 2018
Edwards Lifesciences gets CE mark for advanced heart valve
Nov. 19, 2018
Medtronic aneurysm repair device proves durable in complex cases
Nov. 19, 2018
Boston Scientific to spend over $200M in restructuring
Nov. 19, 2018
GE Healthcare recalls nuclear medicine imaging systems
Nov. 16, 2018
Owens & Minor names interim chairman and CEO
Nov. 9, 2018
Long-term data backs Medtronic drug-coated balloon for PAD
Nov. 7, 2018
FDA clears Siemens Healthineers mobile 3D imaging arm
Nov. 7, 2018
Becton Dickinson Q4 revenue up, some Wall Street misses
Nov. 6, 2018
FDA approves 2 devices to aid in thyroid surgery
Nov. 5, 2018
Pact to rush medical products for military clinched
Nov. 5, 2018
FDA extends time to comply on unique device identification
Nov. 5, 2018
FDA deficient on device cybersecurity readiness, watchdog says
Nov. 2, 2018
NuVasive CEO says spine industry poised to consolidate
Oct. 31, 2018
Baxter earns CE mark for new renal replacement system
Oct. 30, 2018
Genentech releases more data on refillable eye implant
Oct. 30, 2018
FDA panel to review first-of-a-kind heart failure device
Oct. 29, 2018
Philips launches all-in-one breast ultrasound product
Oct. 29, 2018
Drug-delivery device developer snags Sanofi as investor
Oct. 29, 2018
Stryker touts benefits of Mako robot on knee outcomes, costs
Oct. 26, 2018
Edwards Lifesciences Q3 sales up 10%
Oct. 24, 2018
Quest disappoints with full year revenue forecast cut
Oct. 23, 2018
Heater-cooler device redesigned to limit infections: FDA
Oct. 22, 2018
Abbott HeartMate 3 gets OK as transplant alternative
Oct. 22, 2018
Stryker asks to extend anti-trust deadline for K2M deal
Oct. 22, 2018
Intuitive Surgical sees 20% growth in da Vinci robot use
Oct. 19, 2018
FDA clears Pfizer PARP drug, Myriad companion test for breast cancer
Oct. 17, 2018
Medtronic sells workflow tool to boost its opioid pump
Oct. 17, 2018
J&J posts softer Q3 device sales
Oct. 16, 2018
Health apps require robust regulatory approach: JAMA opinion
Oct. 15, 2018
CT scans can diagnose complex heart disease, study shows
Oct. 15, 2018
FDA to fund pediatric medical device consortium
Oct. 15, 2018
TransEnterix wins FDA nod for smaller robotic instruments
Oct. 12, 2018
FDA OKs DNA-based test for blood transfusion compatibility
Oct. 12, 2018
RightEye's eye-tracking system gets FDA clearance
Oct. 10, 2018
Siemens' latest 1.5T MRI scanner gets FDA nod
Oct. 10, 2018
Researchers develop biodegradable nerve stimulation device
Oct. 9, 2018
Eximo Medical gains FDA clearance for atherectomy laser
Oct. 9, 2018
1 in 5 health IT execs say malware has hit devices
Oct. 8, 2018
Bose self-fitting hearing aid gets FDA approval
Oct. 8, 2018
Prostate cancer imaging agent meets one of two study endpoints
Oct. 8, 2018
Fitbit rolling out Charge 3 with focus on sleep tracking
Oct. 5, 2018
Baxter, Mayo team up on outpatient kidney care center
Oct. 3, 2018
Artificial pancreas has edge over insulin pump therapy in study
Oct. 3, 2018
Stryker settles foreign corrupt practice charges, makes small acquisition
Oct. 2, 2018
FDA, ECRI, device group keep up drumbeat on cybersecurity risks
Oct. 2, 2018
FDA finds fault with some insulin pen use directions
Oct. 1, 2018
Doctor survey finds strong interest in new urology devices
Oct. 1, 2018
FDA clears NGS test to detect residual blood cancer cells
Oct. 1, 2018
Hologic acquires developer of breast cancer surgery marker
Sept. 28, 2018
Global device industry set to grow 5.6% a year through 2024: report
Sept. 26, 2018
Medtronic launches Infinity spine fusion system
Sept. 26, 2018
Medtronic CoreValve proves durable in longer-term data
Sept. 25, 2018
FDA gives final guidance on device benefits, risks in 510(k) submissions
Sept. 25, 2018
Boston Scientific's Eluvia wins FDA nod, seen as effective as Cook's Zilver in study
Sept. 24, 2018
Medtronic heart stent works as well as thin-strut Orsiro: study
Sept. 24, 2018
Abbott's MitraClip keeps more heart valve patients alive in study
Sept. 24, 2018
Medicare lab test spending up slightly in 2017: OIG
Sept. 21, 2018
Medtronic to study TAVR in low-risk bicuspid patients
Sept. 19, 2018
Ra Medical amends IPO plan
Sept. 19, 2018
AI can identify lung cancer types in images, study finds
Sept. 18, 2018
NIH funds study of artery imaging without contrast dyes
Sept. 18, 2018
Stent to seal coronary artery perforations gets FDA nod
Sept. 17, 2018
FDA defends its work on breast implant safety
Sept. 17, 2018
FDA tests new way to shorten 510(k) review times
Sept. 17, 2018
Gottlieb: FDA pursuing faster approval path for diagnostics
Sept. 14, 2018
FDA advised to step up device cybersecurity checks premarket
Sept. 12, 2018
Companion diagnostic for bile duct cancer treatment in works
Sept. 12, 2018
A call to make EHRs safer for pediatric patients
Sept. 11, 2018
Medtronic to study one month of DAPT in high-bleeding-risk patients
Sept. 11, 2018
FDA raises concerns about feeding tube misconnections
Sept. 10, 2018
Becton Dickinson sells bioprocessing business to Thermo Fisher
Sept. 10, 2018
Bundled payment model cuts joint replacement costs in study
Sept. 10, 2018
FDA clears new version of Baxter bone graft substitute
Sept. 7, 2018
Livongo adds continuous glucose data via Abbott's FreeStyle Libre
Sept. 7, 2018
Developing afib after valve implant raises risks, study finds
Sept. 5, 2018
Cigna names chief data and analytics officer
Sept. 5, 2018
Otsuka rolls out Abilify digital pill through Magellan network
Sept. 4, 2018
European Society of Cardiology endorses iFR in guidelines
Sept. 4, 2018
Stryker buys spine device maker K2M for $1.4B
Aug. 31, 2018
Medtronic cryoballoon reduces persistent afib symptoms in study
Aug. 31, 2018
SynCardia stands behind its artificial heart driver
Aug. 29, 2018
Balloons as effective as stents to open small arteries, study says
Aug. 29, 2018
FDA warns Zimmer Biomet about quality violations at Indiana plant
Aug. 28, 2018
Medication reminder apps for heart patients could save lives, study says
Aug. 28, 2018
DexCom acquires maker of insulin dosing algorithm
Aug. 27, 2018
Patients getting needed supplies under DME bidding: GAO
Aug. 27, 2018
Hands-free device may track astronauts' vital signs in space
Aug. 27, 2018
Robotic surgery market is about to get crowded, report says
Aug. 24, 2018
FDA approves Keytruda companion test for bladder cancer
Aug. 22, 2018
NIST offers guide to securing wireless infusion pumps
Aug. 22, 2018
Diabetes, heart device sales drive strong Medtronic Q1
Aug. 21, 2018
Doctors often fail to list conflicts in device studies: JAMA report
Aug. 20, 2018
Noninvasive magnetic stimulation for OCD wins FDA nod
Aug. 20, 2018
FDA finds higher death, stroke rates for latest SynCardia artificial heart driver
Aug. 20, 2018
Early A1C test may reduce gestational diabetes risk: NIH study
Aug. 17, 2018
Healthix switching software vendors for patient matching
Aug. 15, 2018
Maryland failed to secure its Medicaid data: OIG
Aug. 15, 2018
BARDA, J&J team to crowdsource respiratory device ideas
Aug. 14, 2018
FDA approves one-year contraceptive ring
Aug. 14, 2018
NuVasive, Siemens partner on spine surgery imaging
Aug. 13, 2018
Most recalled foot, ankle devices are 501(k) approved, study finds
Aug. 13, 2018
FDA OKs marketing of contraceptive app
Aug. 13, 2018
Medtronic begins study of ICD with leads outside the heart
Aug. 10, 2018
Burn treatment earns expanded compassionate use approval
Aug. 10, 2018
MDLive, Beacon partner on virtual behavioral health visits
Aug. 8, 2018
Senseonics rolls out 90-day continuous glucose monitoring
Aug. 8, 2018
New blood test can rule out heart attack faster
Aug. 7, 2018
Varian acquires maker of patient monitoring system
Aug. 7, 2018
Cardinal Health posts Q4 loss as Cordis struggles
Aug. 6, 2018
FCC seeks comments on $100M telehealth pilot
Aug. 6, 2018
Abbott device to treat Parkinson's now MRI-compatible
Aug. 3, 2018
FDA approves Medtronic implant for rare form of hypertension
Aug. 1, 2018
CSI, Aerolase partner on laser atherectomy device
Aug. 1, 2018
FDA warns about vaginal 'rejuvenation' device claims
July 31, 2018
CMS advisers split on procedure volume rules for TAVR
July 30, 2018
FDA sets 2019 medical device user fee rates
July 30, 2018
FDA approves Abbott's blood sugar sensor for 14-day use
July 30, 2018
CMS pitches covering cardiac catheterization at surgical centers
July 30, 2018
FDA gives draft guidance on atherectomy device submissions
July 27, 2018
Stryker says Q2 tops goals, will stick to M&A playbook
July 25, 2018
Quest Diagnostics posts slight Q2 revenue miss
July 24, 2018
Bayer to stop selling Essure birth control implant in US
July 23, 2018
NIH center makes public a trove of CT images for research
July 23, 2018
Tendyne investors sue Abbott over lost milestone payment
July 23, 2018
Intuitive Surgical profit up on strong da Vinci robot sales
July 20, 2018
Calls to revamp physician self-referral law grow louder
July 18, 2018
FDA reiterates concern about off-label use of bile-duct stents
July 18, 2018
Device industry lobbies FDA on combo product classification
July 17, 2018
J&J says medical device sales improve in second quarter
July 17, 2018
Abbott device to repair leaky heart valves approved
July 16, 2018
CMS targets data gaps in setting lab payments
July 16, 2018
Medtronic, UnitedHealthcare say value-based pact cut diabetes costs
July 11, 2018
Stryker names new president, tweaks leadership structure
July 11, 2018
Better cybersecurity safeguards urged for medical devices, EHRs
July 10, 2018

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