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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. european commissionmedtech divetargetsspringfully 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... medtech divecongresseyestacklinghealthcare 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... hearing devicesmedtech divefdawarnsrisks 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... boston scientificas effectivemedtech diveeluviawins 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... so longmedtech divetakenquestclear 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. medtech divepulsedropsplanpfa 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... medtech divefdaapprovesupdatedcovid 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... seal the dealboston scientificmedtech divevarianbeads 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... erik toddmedtech diveolympusbackedswan 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. thermo fisherlay offmedtech divecaliforniaworkers 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... in officemedtech diveamidpricingtumult 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... aortic valve replacementmedtech diverisetavrincreased 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. medical deviceuser feemedtech divefallingfda 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. tuck indeals tomedtech divepitchbookdrive Sponsored https://www.litlatinz.com/enter.php?prg=1&id=robuta&t=best&ad_id=litlatinz_315x300_phoneswap.gif LitLatinz Date with some spice. Join for free to meet sexy local Latinas. 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. de novomedtech divemmireceivesnod 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. chief medical officerdigital healthmedtech divewhoophires 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. medtech divecuehealthcutemployees 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.” combination productmedtech divefdafinalizesguidance 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. medtech divepreparesrelaunchalarispump 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. surgical lightingmedtech divestrykerbuyscompany 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. medtech diveilluminaassaygetsfda 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... valve guidein europemedtech diveedwardsrecalls 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. brain aneurysmmedtech divestrykerwinsapproval 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... antigen testmedtech diveabbottgetseua 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. medtech divebostoninferiorrivaltavr 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... medtech diveaddshysterectomyindicationaim 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. moves tomedtech diveinsuletfulllaunch 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. wound healingmedtech divesmartbandagesaccelerate 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... medical devicemedtech divefdafundpediatric 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. change controlmedtech divefdaseeksfeedback Sponsored https://www.camsoda.ai/?id=robuta&ad_id=ai_300x250_25 Camsoda AI: AI Girlfriend App for Chatting, Photos, and Voice Camsoda AI is the AI girlfriend app for real-time chat, photos, and voice. 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Free to start. 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. medtech divebiotronikstentbeatsabbott 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. medtech divedevicesneeddedicatedfda 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. insulin pumpmedtech diveinsuletwarnscharge 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. medtech divetopdevicefirmsreport 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. proof of conceptknow labsmedtech divehopesadvance 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... ce marksurgical robotmedtech divewinshinotori Sponsored https://www.xlovecam.com/prm03/textlink?id_affilie=26457&p=online&tri=10 Best Live Sex Cam Shows with Free Live Chat | XLoveCam Watch thousands of cam girls get naked on XLoveCam. 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. bankruptcy protectionsupply chainmedtech diveinvacarefiles 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... spotlight onmedtech divemedtronichopesrenewed 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. system monitormedtech diveabbottissuesrecall 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... medtech diveedwardsissuessafetynotice 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. glucose monitorce markmedtech divewearablewins 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. digital healthmedtech dive 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... ge healthcaresupply chainmedtech divehitconstraints 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. 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