Featured Stories
News We’re Watching: Telehealth Advances; AI Regulation; NIH Backs SIRT; Oura Upgraded
This week, a House subcommittee advanced a two-year telehealth extension, Chuck Schumer and a bipartisan group of senators introduced a plan for regulating AI, the FDA launched its new online RST Catalog, NIH recommends targeted radiotherapy cancer treatment, and Oura announced new health features for its smart ring.
Mid-May MDCG Mandate Madness: Pre-empting Questions On Investigator Brochures
Newly issued EU guidance documents make it easier for device companies to draft clinical investigation brochures that will pass authority inspection. They also give insight into what notified body designating authorities check for.
FDA Grants De Novo Marketing Authorization For At-Home Retinal Imaging Device
Notal Vision, a Virginia-based patient-centric ophthalmic remote monitoring services provider, has won de novo marketing authorization from the US FDA for a product that allows patients to keep tabs on their age-related macular degeneration while at home.
Deals Shaping The Medtech And Diagnostics Industries, April 2024
An interactive look at medtech and diagnostics deals made during April 2024. Data courtesy of Biomedtracker.
Spotlight On Conferences
At-Home Health Testing Demand Is High Post-Pandemic, But So Are Barriers To Development And Use
At the recent Precision Med-Tri Con conference, laboratory experts traded views on the expansion of at-home testing for disease diagnosis and personalized health insights. While strong consumer demand spells opportunity, there are significant concerns about the accuracy and reliability of home-testing platforms, misuse, accessibility, and lack of health literacy.
‘Biggest Transformation In The History Of Medicine’: Oncologist And Cardiologist Talk AI-Enabled Health Care
A More Cautious Approach To AI, And Other Policy And Regulation Trends From HIMSS 24
Creating Standards For Responsible AI In Health Care
Imagining Cybersecurity As An Ecosystem: From Regulations To Resiliency
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Cardio Conversations: ‘Much More Than Just A Patch.’ iRhythm CEO Blackford Talks AI Arrhythmia DiagnosticsListen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics.
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