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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.

News We're Watching Artificial Intelligence Approvals

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.

Europe EU Medical Device

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.

FDA OTC Devices Ophthalmology

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.

Deals Financing M & A

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.

Innovation In Vitro Diagnostics

Medtech Insight Podcasts


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Cardio Conversations: ‘Much More Than Just A Patch.’ iRhythm CEO Blackford Talks AI Arrhythmia Diagnostics
 

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