https://www.medtechdive.com/news/european-commission-eudamed-timeline-2024/626917/
European Commission targets spring of 2024 for fully functional Eudamed database | MedTech Dive
The Commission is planning a two-phase transition to mandatory use of the database after it goes live.
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https://www.medtechdive.com/news/house-budget-committee-healthcare-affordability-consolidation/810468/
Congress eyes tackling healthcare consolidation | MedTech Dive
“I think there’s common ground here,” one Republican congressman said Wednesday during a House Budget Committee hearing. Squaring up against healthcare...
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https://www.medtechdive.com/news/fda-warns-of-risks-when-shunt-implants-hearing-devices-mix/558909/
FDA warns of risks when shunt implants, hearing devices mix | MedTech Dive
Because magnetic field interference between implanted shunts and hearing devices may cause unintended changes to valve settings, the agency advises...
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https://www.medtechdive.com/news/boston-scientifics-eluvia-wins-fda-nod-seen-as-effective-as-cooks-zilver/533014/
Boston Scientific's Eluvia wins FDA nod, seen as effective as Cook's Zilver in study | MedTech Dive
Results of the first head-to-head clinical trial to compare the two drug-eluting stents to treat leg artery blockages were presented at a scientific meeting...
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https://www.medtechdive.com/news/why-its-taken-quest-so-long-to-clear-its-covid-19-testing-backlog/583706/
Why it's taken Quest so long to clear its COVID-19 testing backlog | MedTech Dive
The lab giant trailed chief rival LabCorp in turnaround times for most of July, slowed down by geography and the makeup of its customer base. Quest finally...
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https://www.medtechdive.com/news/pulse-seeks-fda-approval-pfa-clamp/720806/
Pulse drops 510(k) plan for PFA device after FDA requests clinical data | MedTech Dive
Analysts said the AFib device is now unlikely to come to market before late 2026.
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https://www.medtechdive.com/news/covid-booster-fda-approval-pfizer-moderna-xbb-omicron/693393/
FDA approves updated COVID boosters from Pfizer, Moderna | MedTech Dive
Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect to make the reformulated shots available in the U.S. in the coming...
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https://www.medtechdive.com/news/boston-scientific-to-offload-beads-clearing-way-for-btg-acquisition/558045/
Varian, Boston Scientific seal the deal on beads business transfer | MedTech Dive
Varian Medical Systems said Wednesday it completed the $90 million purchase of Boston Scientific's drug-loadable microspheres and bland embolic beads, a...
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https://www.medtechdive.com/news/Olympus-backed-Swan-EndoSurgical-Erik-Todd-CEO/807127/
Olympus-backed Swan EndoSurgical names Erik Todd as CEO | MedTech Dive
Swan highlighted Todd’s experience in scaling robotic platforms, building global engineering organizations and driving innovation across endoscopy and...
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https://www.medtechdive.com/news/thermo-fisher-lay-off-workers-california/703743/
Thermo Fisher to lay off 74 California workers in restructuring | MedTech Dive
The scientific instruments maker, which has been streamlining operations to cut costs, said the latest job reductions would be effective Feb. 1.
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https://www.medtechdive.com/news/amid-pricing-tumult-irhythm-ceo-resigns-after-4-months-in-office/601113/
Amid pricing tumult, iRhythm CEO resigns after 4 months in office | MedTech Dive
After taking over on Jan. 12, Mike Coyle stepped down Tuesday. CFO Douglas Devine will assume the role amid a search for a permanent replacement. Shares were...
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https://www.medtechdive.com/news/tavr-increase-boosted-overall-aortic-valve-replacements-jacc/610492/
Rise of TAVR increased overall aortic valve replacement, improved outcomes: study | MedTech Dive
The growth of transcatheter procedures has driven a 60% increase in aortic valve replacement and cut one-year mortality in older adults, according to data...
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https://www.medtechdive.com/news/falling-fda-personnel-costs-soften-2021-medical-device-user-fee-hike/582581/
Falling FDA personnel costs soften 2021 medical device user fee hike | MedTech Dive
The agency's required user fees for medical device submissions will rise 7.2% beginning in October.
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https://www.medtechdive.com/news/pitchbook-merger-acquisition-acceleration-2026/806872/
PitchBook: AI tuck-in deals to drive M&A acceleration in 2026 | MedTech Dive
Buyers will focus on “tuck-ins that add AI or data-driven capabilities or can meaningfully improve scale against emerging competitors,” the analysts said.
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https://www.medtechdive.com/news/mmi-symani-robot-microsurgery-fda/712632/
MMI receives de novo nod for microsurgery robot | MedTech Dive
Medical Microinstruments said the system could increase the number of physicians who can perform complicated microsurgical procedures.
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https://www.medtechdive.com/news/whoop-hires-fda-digital-health-committee-chair-as-chief-medical-officer/825949/
Whoop hires FDA digital health committee chair as chief medical officer | MedTech Dive
Ami Bhatt is joining the company as it makes a broader push into health.
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https://www.medtechdive.com/news/cue-health-layoffs-half-workforce/715058/
Cue Health to cut 230 employees | MedTech Dive
Declining COVID-19 test sales have forced Cue to eliminate hundreds of jobs in multiple rounds of layoffs over the past several years.
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https://www.medtechdive.com/news/FDA-finalizes-combination-product-guidance/693498/
FDA finalizes combination product guidance 7 years after sharing draft | MedTech Dive
AdvaMed called overlapping human factor requirements of the draft guidance “overly burdensome.”
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https://www.medtechdive.com/news/BDX-bd-q3-earnings-alaris-clearance/689870/
BD prepares for relaunch of Alaris pump, raises revenue forecast | MedTech Dive
The pump relaunch isn’t expected to contribute much to this year’s revenue, but could help Becton Dickinson reach its long-term financial goals.
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https://www.medtechdive.com/news/stryker-buys-surgical-lighting-company-for-190m/532065/
Stryker buys surgical lighting company for $190M | MedTech Dive
Photonics and intracavity lighting company Invuity is the latest acquisition in Stryker's ongoing purchasing spree.
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https://www.medtechdive.com/news/illumina-trusight-assay-gets-fda-breakthrough-designation/546626/
Illumina TruSight assay gets FDA breakthrough designation | MedTech Dive
The DNA sequencing company is seeking clearance of the assay as a companion diagnostic.
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https://www.medtechdive.com/news/edwards-recalls-pascal-valve-guide-sheath-in-europe-amid-potential-for-embo/567500/
Edwards recalls Pascal valve guide sheath in Europe amid potential for embolizations | MedTech Dive
A manufacturing problem resulting in damage to the inner lining of the sheath in fewer than 1% of devices prompted the recall. No adverse events were linked to...
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https://www.medtechdive.com/news/stryker-wins-approval-for-brain-aneurysm-stent-system/555221/
Stryker wins approval for brain aneurysm stent system | MedTech Dive
The product, designed to treat wide-neck intracranial aneurysms, adds to the company's rapidly growing neurovascular portfolio.
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https://www.medtechdive.com/news/abbott-gets-eua-for-rapid-5-covid-19-antigen-test/584232/
Abbott gets EUA for rapid $5 COVID-19 antigen test | MedTech Dive
As the fourth company to get the FDA emergency nod, the medtech giant's scale makes it a "significant entry [that] could help democratize testing," said former...
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https://www.medtechdive.com/news/Boston-TAVR-Acurate-Neo2-valve-trial-TCT/731560/
Boston Scientific’s Acurate Neo2 inferior to rival TAVR valves in study | MedTech Dive
Analysts said the findings complicate the outlook for a U.S. launch of Boston Scientific's aortic valve replacement device.
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https://www.medtechdive.com/news/Distalmotion-hysterectomy-AiM-Medical-Robotics-funding/801724/
Distalmotion adds hysterectomy indication; AiM raises funds for neurosurgical robot | MedTech Dive
The clearance gives Distalmotion, which sees opportunity in ambulatory settings, a third robotic procedure category in the U.S. Elsewhere, AiM Medical Robotics...
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https://www.medtechdive.com/news/insulet-omnipod-5-market-release/628535/
Insulet moves to full launch of Omnipod 5 | MedTech Dive
BTIG analysts said the shift reflects success with user experience and logistics during a limited market release.
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https://www.medtechdive.com/news/stanford-smart-bandage-wound-healing/638168/
Stanford’s smart bandages accelerate wound healing in preclinical tests | MedTech Dive
The bandages deliver electrical stimulation to accelerate wound healing in mice by 25% compared to standard sterile dressings.
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https://www.medtechdive.com/news/fda-to-fund-pediatric-medical-device-consortium/539642/
FDA to fund pediatric medical device consortium | MedTech Dive
Led by Children's National Health System in Washington and the University of Maryland, College Park, the effort will connect individuals who have pediatric...
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https://www.medtechdive.com/news/fda-guidance-predetermined-change-control-plan/725191/
FDA seeks feedback on predetermined change control plans | MedTech Dive
The guidance describes changes companies can make to medical devices without filing a new 510(k) or premarket approval supplement.
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https://www.medtechdive.com/news/biotroniks-orsiro-stent-beats-abbotts-xience-in-head-to-head-trial/562184/
Biotronik's Orsiro stent beats Abbott's Xience in head-to-head trial | MedTech Dive
The trial linked the "ultrathin" Orsiro to a lower rate of target lesion revascularization than Abbott's incumbent device.
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https://www.medtechdive.com/news/AI-healthcare-bias-FDA-rules-pathway/642911/
AI devices need dedicated FDA regulatory pathway to reduce bias risk, say researchers | MedTech Dive
Scientists argue for a new regulatory process to prevent AI software from reinforcing existing health disparities.
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https://www.medtechdive.com/news/insulet-omnipod-5-insulin-pump-overheat/636795/
Insulet warns Omnipod 5 insulin pump charge issue may cause fire | MedTech Dive
Rapid sales growth at the company has come amid safety problems involving some of its devices.
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https://www.medtechdive.com/news/bmj-medical-device-adverse-events-late-reporting/742781/
Top device firms report safety data late: BMJ | MedTech Dive
BD, Medtronic and Abbott were among the top 10 device companies with the highest number of late reports to the FDA, the study found.
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https://www.medtechdive.com/news/know-labs-non-invasive-cgm-progress/648499/
Know Labs hopes to advance non-invasive glucose sensor with proof-of-concept test | MedTech Dive
The company wants to use its Bio-RFID technology for glucose monitoring, and recently showed the device could detect and quantify specific molecules in water.
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https://www.medtechdive.com/news/medicaroid-wins-europes-ce-mark-for-hinotori-surgical-robot/824959/
Medicaroid wins Europe’s CE mark for Hinotori surgical robot | MedTech Dive
The Japanese medical robotics company, a joint venture between Kawasaki and Sysmex, is preparing for a European launch after expanding in the Asia-Pacific...
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https://www.medtechdive.com/news/Invacare-bankruptcy-IVC/641954/
Invacare files for Chapter 11 bankruptcy protection amid supply chain woes | MedTech Dive
The wheelchair maker said it has reached a restructuring agreement with most of its debt holders and that demand for its products remains strong.
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https://www.medtechdive.com/news/medtronic-hopes-for-renewed-spotlight-on-dialysis-access-device-with-nejm-p/583890/
Medtronic hopes for renewed spotlight on dialysis access device with NEJM publication | MedTech Dive
The company-funded study in the New England Journal of Medicine comes amid widespread disruption of vascular access procedures, and nine months after Medtronic...
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https://www.medtechdive.com/news/abbott-recall-heartmate-system-monitor/718598/
Abbott issues recall for Heartmate system monitor | MedTech Dive
Abbott’s heart pump system and related products have been part of multiple Class I recalls this year.
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https://www.medtechdive.com/news/edwards-issues-safety-notice-for-centera-valve-after-reports-of-injury-dea/558222/
Edwards issues safety notice for Centera valve after reports of injury, death | MedTech Dive
The company said difficulty manipulating the device around the aortic arch has resulted in reports of vascular injury, and recommended use of a stiffer guide...
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https://www.medtechdive.com/news/wearable-glucose-monitor-wins-ce-mark-as-market-gets-crowded/555920/
Wearable glucose monitor wins CE mark, as market gets crowded | MedTech Dive
Nemaura Medical said it intends for its disposable SugarBeat adhesive patch system to compete aggressively on price.
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https://www.medtechdive.com/topic/digital-health/?page=2
Digital Health | MedTech Dive
The latest news in digital health for professionals in the medtech industry.
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https://www.medtechdive.com/news/ge-healthcare-q1-2022-supply-chain-inflation-pressures/622683/
GE Healthcare hit by supply chain constraints, inflation pressures | MedTech Dive
"We're operating in a challenging macro environment," GE CEO Larry Culp said during a first-quarter earnings call, while also noting COVID-19 lockdowns in...
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https://www.medtechdive.com/news/covid-19-antigen-testing-on-par-with-pcr-when-used-often-nih-funded-study/602711/
COVID-19 antigen testing on par with PCR when used often: NIH-funded study | MedTech Dive
The two diagnostic methods were equally effective in detecting SARS-CoV-2 infection. The results could be good news for antigen test makers Abbott, Becton...
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https://www.medtechdive.com/news/abbott-new-diabetes-leader-q-and-a/750631/
Abbott’s new diabetes leader on latest sensors, partnerships and Type 2 coverage | MedTech Dive
Ahead of the American Diabetes Association’s Scientific Sessions, Chris Scoggins said Abbott’s ambition is to be the most broadly connected diabetes tech...
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