https://www.medtechdive.com/news/tavr-for-low-risk-patients-in-spotlight-at-acc/550175/
Jefferies analysts predict results from valve makers Edwards Lifesciences and Medtronic will "usher in the low risk era for...
lowriskpatientsspotlightacc
https://www.medtechdive.com/news/eu-antitrust-surprise-inspection-cardiovascular-device/694213/
The unnamed company may have violated EU rules against abusing a dominant market position, the European Commission said.
euantitrustofficialsmakesurprise
https://www.medtechdive.com/news/ILMN-Grail-Illumina-letter-cancer/652040/
The erroneous letters from telemedicine provider PWNHealth come as Grail’s parent company, Illumina, is facing pressure from regulators and shareholders to...
grailvendorglitchpatientnotifications
https://www.medtechdive.com/news/cdc-rule-removes-barrier-to-sale-of-escape-respirators/553118/
The deregulatory action was inspired by concern that underground coal miners could face a dangerous shortage of the breathing devices, relied on as a means...
cdcruleremovesbarriersale
https://www.medtechdive.com/news/zimmer-stryker-jj-q4-robotics-omicron/618479/
Zimmer Biomet, Stryker and Johnson & Johnson's businesses endured more pressures tied to the postponement of elective procedures in the...
robotscushionomicronblowdevice
https://www.medtechdive.com/news/jj-fda-ide-ottava-surgical-robot/699013/
The company expects to file a submission for an investigational device exemption in the second half of 2024 that will allow it to begin clinical trials for...
jamptargetsottavafda
https://www.medtechdive.com/news/fda-digital-health-pilot-cms-tempo/807374/?utm_source=xtelligent&utm_medium=referral&utm_campaign=Xtelligent-Healthcare-Dive-Site-Cross-Promo
Companies can ask the FDA to waive premarket authorization and investigational device requirements while they collect real-world data in a CMS program.
digital healthfdapilotsallowingdevices
https://www.medtechdive.com/news/healthcare-technology-outlook-predictions-2025/737558/
How the incoming Trump administration will regulate AI this year remains unclear. Meanwhile, experts say healthcare companies will continue bolstering cyber...
healthcare technologymedtech divetoptrends
https://www.medtechdive.com/news/cms-data-sharing-initiative-lacks-detail-data-security-provider-resources-challenges/758401/
Improving health data exchange is a worthy goal, but the initiative has to overcome challenges like data security, under-resourced providers and slow...
white housedata sharingplanboastsbig
https://www.medtechdive.com/news/fda-grants-eua-for-first-fully-at-home-covid-19-test-without-a-prescription/592235/
The rapid antigen test from Australian company Ellume will be available over the counter for people with or without symptoms and delivers results in about 20...
fdagrantseuafirstfully
https://www.medtechdive.com/news/medtronic-faces-key-test-in-renal-denervation/571972/
After a setback six years ago, the medtech giant is set to unveil pivotal trial data next month on a procedure to lower blood pressure. Abbott and Boston...
medtronicfaceskeytestestablishing
https://www.medtechdive.com/news/Medtronic-Hugo-FDA-submission-urology/746489/
William Blair analyst Brandon Vazquez said 2025 could be the first year market leader Intuitive Surgical will face meaningful U.S. competition.
fda approvalmedtronicsubmitshugosoft
https://www.medtechdive.com/news/fda-approves-abbotts-blood-sugar-sensor-for-14-day-use/528888/
The system was the first continuous glucose monitor to eliminate the need for routine finger prick tests.
blood sugarfdaabbottsensor
https://www.medtechdive.com/news/Medtronic-MDT-hemodialysis-catheter-recall/641571/
The FDA reported two injuries tied to the problem, which could cause leaks across the tubes of the implanted catheters and produce blood clots.
medtronicrecallshemodialysiscatheterspotential
https://www.medtechdive.com/news/fda-ecri-device-group-keep-up-drumbeat-on-cybersecurity-risks/538635/
The agency is launching a cybersecurity playbook for healthcare providers and said it will publish a "significant update" to its 2014...
cybersecurity risksfdadevicegroupkeep
https://www.medtechdive.com/news/rapid-diagnostic-test-detects-ebola-malaria-in-the-field/544382/
The portable test can detect Ebola and other viruses in under 30 minutes from a single blood sample.
rapiddiagnostictestdetectsebola
https://www.medtechdive.com/news/medtronic-corevalve-proves-durable-in-longer-term-data/533148/
Severe hemodynamic structural valve deterioration was 0.8% for CoreValve versus 1.8% for surgery across five years, with similar rates of mortality and major...
medtech divemedtronicprovesdurablelonger
https://www.medtechdive.com/news/fda-warns-breast-infrared-imaging-tool-should-not-replace-mammography/549181/
Total Thermal Imaging's thermography system has not been cleared as a standalone diagnostic tool, and the technology lacks scientific evidence to...
fdawarnsbreastinfraredimaging
https://www.medtechdive.com/news/edwards-recalls-two-heart-catheters-used-in-infants/553618/
The devices are used to correct complex congenital heart defects after birth.
medtech diveedwardsrecallstwoheart
https://www.medtechdive.com/news/cook-medical-aortic-dissection-device-gets-fda-approval/547679/
The device is designed to repair Type B dissections of the descending thoracic aorta in a minimally invasive procedure.
aortic dissectionfda approvalmedtech divecookmedical
https://www.medtechdive.com/news/thermo-fisher-buys-olink-31b-proteomics/696820/
Olink’s high-throughput protein analysis technology is expected to complement Thermo Fisher’s mass spectrometry and life sciences platforms.
thermofisherbuysholdingpushing
https://www.medtechdive.com/news/genentech-releases-more-data-on-refillable-eye-implant/540916/
Study results showed that vision and anatomical outcomes in wet AMD patients who received the device, and dosed every six months or longer, were comparable to...
medtech divegenentechreleasesdatarefillable
https://www.medtechdive.com/news/eu-group-offers-guidance-on-meeting-mdrs-cybersecurity-standards/569906/
The document says it's important to reference the International Medical Device Regulators Forum's cybersecurity guidance, and policies...
group offerseuguidancemeetingmdr
https://www.medtechdive.com/news/hospital-buying-data-point-to-tavr-surge-in-q3-analysts/562446/
Use of Edwards Lifesciences' systems is accelerating sharply in the third quarter, according to a Jefferies model, suggesting hospitals anticipated...
data pointhospitalbuyingsurgeanalysts
https://www.medtechdive.com/news/Roche-rights-Freenome-cancer-tests-outside-US/806006/
Analysts said the deal shows Roche’s long-term strategy for its sequencing technology is “a clinical box for running NGS kits, similar to with their prior...
rocheinksdealrightsfreenome
https://www.medtechdive.com/news/oig-issues-alert-on-genetic-testing-scam/556118/
Scammers are trying to get personal information from Medicare beneficiaries by offering genetic testing through telemarketing calls, booths at public events,...
genetic testingmedtech diveoigissuesalert
https://www.medtechdive.com/news/abbott-heartmate-recall-pump-stop/709961/
The FDA said eight reported injuries have been linked to the problem, which can cause the mechanical heart pump to unexpectedly stop or start.
medtech diveabbottrecallscommunicationsystem
https://www.medtechdive.com/news/ecri-institute-launching-international-device-testing-lab/551595/
The nonprofit patient safety organization will open its first medical device evaluation laboratory outside the United States on April 11 in Selangor, Malaysia,...
medtech diveinstitutelaunchinginternationaldevice
https://www.medtechdive.com/news/fda-lab-developed-test-chevron-supreme-court/721085/
The Supreme Court’s decision to overturn the Chevron doctrine would make it easier to challenge agency regulations, such as the LDT final rule.
labdevelopedtestrulecould
https://www.medtechdive.com/news/advamed-digital-health-division-board/696050/
The new division will focus on four core policy priorities under Chair Taha Kass-Hout, chief technology officer at GE HealthCare.
digital healthcenterdivisionnamesboard
https://www.medtechdive.com/news/thermo-fisher-lay-off-workers-california/703743/
The scientific instruments maker, which has been streamlining operations to cut costs, said the latest job reductions would be effective Feb. 1.
thermofisherlaycaliforniaworkers
https://www.medtechdive.com/news/cybersecurity-priorities-laid-out-by-key-house-panel/543942/
The House Energy and Commerce Committee issued a report outlining six strategies for strengthening the nation's defenses against cybersecurity...
medtech divecybersecurityprioritieslaidkey
https://www.medtechdive.com/news/Staar-Surgical-layoffs-California-China-slowdown/741004/
Staar’s job cuts come “amid ongoing macroeconomic and geopolitical challenges that have pressured the business,” a spokesperson said. Demand in China,...
surgicallaypeoplecaliforniamedtech
https://www.medtechdive.com/news/jjs-pulsed-field-ablation-ce-mark-europe/708881/
The device maker will vie against rivals Boston Scientific and Medtronic in the market for the new treatment for atrial fibrillation.
jampfieldablationsystem
https://www.medtechdive.com/news/oncology-systems-maker-varian-ekes-out-sales-gain-amid-procedure-delays/577344/
The company managed a 2% uptick in Q2 revenues despite the slowdown in non-essential procedures as people postponed routine screenings, which in turn has...
oncologysystemsmakervariansales
https://www.medtechdive.com/news/Boston-Scientific-fda-approval-Agent-drug-coated-coronary-balloon/709053/
BTIG analyst Marie Thibault said physicians could rapidly adopt the first-of-its-kind device.
boston scientificgainsfdanoddrug
https://www.medtechdive.com/news/fda-endorses-open-database-for-genetic-variants/543625/
The agency said it hopes the move will encourage database administrators to submit genetic variant information to publicly accessible databases, with the aim...
medtech divefdaendorsesopendatabase
https://www.medtechdive.com/news/ILMN-Illumina-Grail-SEC-probe/690713/
The securities regulator has asked for documents tied to the 2021 deal in addition to the conduct and compensation of members of Illumina and Grail management.
medtech diveilluminafacessecprobe
https://www.medtechdive.com/news/moon-surgical-fda-nod-soft-tissue-robot/718090/
Moon joins an expanding list of robot makers aiming to compete in a soft tissue surgery market led by Intuitive Surgical.
moonsurgicalsecuresfdanod
https://www.medtechdive.com/news/fda-philips-sleep-apnea-device-recall-resmed/610026/
The agency has asked Philips Respironics to conduct more safety testing on the sound abatement foam at the center of the sleep apnea and ventilator device...
fdaquestionssafetyphilipsreplacement
https://www.medtechdive.com/news/calls-to-revamp-physician-self-referral-law-grow-louder/528024/
Device makers, lab, imaging and hospital companies all back changes to the Stark law, arguing it impedes the move toward alternative payment and value-based...
callsrevampphysicianselfreferral
https://www.medtechdive.com/news/house-bill-would-speed-cms-coverage-for-breakthrough-medtech/568681/
The bipartisan legislation, reintroduced on Friday, promises faster access to new medical technologies by requiring Medicare to cover devices approved...
housebillwouldspeedcms
https://www.medtechdive.com/news/intuitive-ceo-robot-placements-bariatric-surgery-slowdown/704320/
Speaking at the J.P. Morgan Healthcare Conference, CEO Gary Guthart said the robotics company is also seeing strong growth in general surgeries.
bariatric surgeryintuitiveceostrongrobot
https://www.medtechdive.com/news/illumina-to-buy-SomaLogic-425m/751322/
Illumina said adding SomaLogic would support the company’s multiomics strategy and strengthen the value of its NovaSeq X products.
medtech diveilluminabuy
https://www.medtechdive.com/news/JPM-Medtronic-Intuitive-Surgical-Boston-Scientific-Dexcom/737688/
CEOs from Medtronic, Intuitive Surgical, Boston Scientific and Dexcom were on hand this week in San Francisco to discuss the year ahead at the J.P. Morgan...
recaproboticspfaotcsensors
https://www.medtechdive.com/news/value-based-payment-models-take-hold-in-medtech-but-barriers-slow-shift/574173/
The arrangements are becoming more prevalent, especially for costly devices used in chronic disease management and in hospital settings, according to a recent...
valuebasedpaymentmodelstake
https://www.medtechdive.com/news/Baxter-Q4-earnings-CEO-search/740619/
Interim CEO Brent Shafer said the medical products maker is ready to begin a new era after several years of “heavy lifting” to simplify the business...
toughyearbaxterlooksnext
https://www.medtechdive.com/news/Philips-Edwards-Lifesciences-AI-mitral-valve-repair-collaboration/805912/
Artificial intelligence combines ultrasound and X-ray images to give physicians a real-time 3D view of the repair device during transcatheter heart procedures.
philipsedwardsteamaibased