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1	Elise Reuter MedTech Dive Reporter @MedTechDive. Covers medical devices. medical technologydigital therapeutics	FDA issues final guidance on postmarket updates to AI-enabled devices - 21 days ago FDA issues final guidance on postmarket updates to AI-enabled devices - 21 days ago Medtronic settles pulse oximetry lawsuit alleging inaccuracies - about 2 months ago Legacy medical devices keep regulators up at night - 2 months ago Many FDA-authorized AI devices lack validation data - 4 months ago CMS finalizes notice on Medicare coverage for breakthrough devices - 5 months ago CMS finalizes notice on Medicare coverage for breakthrough devices - 5 months ago FDA official sets out approach to AI in medical devices - 6 months ago Medtech group updates EtO standard for first time in 25 years - 6 months ago Medicare adviser sets recommendations for diabetes device evidence - 7 months ago Philips restricted from selling respiratory machines in DOJ consent decree - 9 months ago FDA re-issues ban on electric shock devices - 9 months ago 6 ways the FDA can improve medical device recalls - 9 months ago FDA drafts guidance outlining real-world evidence for medical device submissions - about 1 year ago The FDA approved 2 renal denervation devices. There are still questions about who will benefit. - about 1 year ago FDA withdraws from Global Harmonization Working Party - about 1 year ago Boston Scientific looks to new devices in 2024 to drive growth - about 1 year ago 5 takeaways from the FDA’s updated list of cleared AI/ML medical devices - about 1 year ago
2	Ricky Zipp MedTech Dive Health Analyst, science master. Brooklyn, New York health analysisscience	FDA plan would alert public sooner on high-risk device recalls - about 1 month ago As cyberattacks on healthcare persist, can the FDA’s new device regs hold up? - 9 months ago FDA extends pandemic-era policy allowing certain device, production changes without prior approval - about 1 year ago Olympus recalls abdominal insufflation devices after reports of patient injuries, one death - about 1 year ago
3	Nick Paul Taylor MedTech Dive Top 5 Mario Kart Player. Gaming	Medtronic buys surgical instrument developer Fortimedix - about 1 month ago FDA warns providers on Getinge devices tied to 17 serious injuries - about 1 month ago FDA prioritizes guidance on lab developed tests in 2025 plan - 2 months ago Medtech Europe calls for urgent reform of MDR and IVDR - 2 months ago FDA’s plan to expand device surveillance faces challenges, GAO finds - 4 months ago Smiths Medical recalls infusion pumps over software issues - 5 months ago Hamilton recalls ventilators that may fail to restart - 5 months ago FDA finalizes guidance on studying opioid use disorder treatments - 6 months ago FDA to expand total product life cycle program - 6 months ago FDA creates transparency principles for AI in medical devices - 6 months ago UK regulator proposes recognizing overseas medical device approvals - 7 months ago Hologic recalls more than 53,000 radiographic markers linked to 71 injuries - 7 months ago EMA updates advice on drug-device combinations under MDR, IVDR - 7 months ago UK sets out position on regulating AI as a medical device - 8 months ago Cook Medical wins contract to supply implants to US Defense Department - 9 months ago MMI receives de novo nod for microsurgery robot - 9 months ago FDA hits Renovo with warning letter over reprocessed medical devices - 9 months ago Abbott receives CE mark for 6-year insertable cardiac monitor - 9 months ago Dexcom, Novo Nordisk call for FDA input on digital diabetes detection devices - 10 months ago Medtronic asks ITC to stop sales, imports of Axonics devices - 10 months ago Hologic’s radiographic markers targeted in FDA safety communication - 10 months ago FDA warns against using smart wearables that claim to measure blood sugar - 10 months ago FDA warns industry of ‘fraudulent’ third-party data in device applications - 10 months ago Medical device recall system ‘failing to meet the needs of public health,’ physicians find - 10 months ago Philips stops selling sleep, respiratory devices in US due to FDA consent decree - 11 months ago Absolutions receives FDA breakthrough designation for abdominal wall closure device - 11 months ago European Commission proposes delays for IVDR to prevent supply disruption - 11 months ago FDA authorizes record number of new devices in 2023 - 11 months ago Imvaria and Darmiyan receive FDA authorizations for AI-enabled diagnostic tools - 11 months ago UK shares roadmap for creation of new medtech regulatory framework - 12 months ago Medtronic secures CE mark for rechargeable Percept deep brain stimulation device - about 1 year ago FDA acts on industry call for clarity about scope of device shortage reporting rules - about 1 year ago FDA-ordered report tackles how to manage cybersecurity risks of legacy devices - about 1 year ago Vicarious delays surgical robot as integration challenges, R&D cuts slow development - about 1 year ago FDA warns providers about using surgical mesh for breast surgery after BD label update - about 1 year ago Philips leader signed off on sale of respiratory devices despite evidence of health risks: report - about 1 year ago FDA finalizes COVID-era guidance, extending flexibility for some remote monitoring devices - about 1 year ago Masimo wins de novo authorization for measure of high blood oxygen levels - about 1 year ago Medtronic posts warning after stolen, defective intubation devices advertised for sale - about 1 year ago FDA expands total product life cycle program to cover neurological devices - about 1 year ago FDA shares draft medical device harmonization plan to meet MDUFA V goal - over 1 year ago Limited resources constrain federal oversight of medical device ads, GAO finds - over 1 year ago FDA releases draft guidance for studying weight loss devices - over 1 year ago FDA finalizes breakthrough device changes to target health inequities - over 1 year ago FDA-ordered report tackles how to manage cybersecurity risks of legacy devices - about 1 year ago
4	Beth Mole Ars Technica Senior Health Reporter @ArsTechnica. microbiologyinfectious diseasespublic health	Horrifying medical device malfunction: Abdominal implant erupts from leg - about 1 month ago
5	Lizzy Lawrence STAT News Medical devices reporter at STATnews. Loves news tips. medical reportingnews	STAT+: New details on a risky medical device show need for more FDA transparency, researchers say - about 1 month ago STAT+: Medical device lobby says it’s tired of waiting on Medicare to cover breakthrough devices - 10 months ago STAT+: FDA warns medical device makers about rise in fabricated data - 10 months ago STAT+: 3 medtech trends to watch in 2024 - 12 months ago
6	Jonathan Gardner MedTech Dive Senior reporter. BioPharma Dive. Charlottesville, Virginia BiopharmaceuticalsJournalism	Novocure wins FDA approval for electric field device in lung cancer - 2 months ago
7	Joyce Frieden MedPage Today Washington editor at MedPage Today. Board member at AHCJ. Greater Washington, DC area Healthcare journalism	What Exactly Is a 'Critical' Medical Device? FDA Seeks Advice on the Issue - 11 months ago
8	Kristina Fiore MedPage Today Explains healthcare complexities. Not endorsements. New York, New York Healthcare journalism	FDA Outlines Rules for Telling Clinicians About Unapproved Uses of Drugs, Devices - about 1 year ago
9	Katie Palmer STAT News Health tech reporter @statnews. JSK Stanford alum. MA health technologysciencejournalism	STAT+: After a lull, the pace of FDA authorization of AI-enabled medical devices is rising - about 1 year ago
10	Casey Ross STAT News National health tech writer @statnews. Covers #AI, #digitalhealth. Cleveland, OH health technologyjournalismartificial intelligencedigital health	STAT+: After a lull, the pace of FDA authorization of AI-enabled medical devices is rising - about 1 year ago

Journalists covering Medical Devices