Quickly uncover the breadth and depth of the editorial offerings found only in MedTech Strategist and Market Pathways – the medtech industry’s leading sources of global business, regulatory, and reimbursement analysis and intelligence on an all-in-one, digital platform. Think Strategically. Subscribe Today
In this week’s Pathways Picks: Australia issues two items navigating the borderlines of medical device regulations for digital health products; UK recommends AI tools for prostate cancer; FDA advances eSubmissions efforts for investigational device exemptions; China publishes transcatheter tricuspid valve guidance; and more from the US, Brazil, and South Korea.
In September, a high-profile FDA advisory committee panel recommended regulatory approval of GRAIL’s multi-cancer early detection screening test, paving the way for a new paradigm in diagnostics. Wall Street and companies working on MCEDs responded favorably, and GRAIL’s stock jumped. The panel opinion has nuances, however, and the next steps will be critical in sorting out an opportunity that is guaranteed to be complicated, as well as exciting.
FDA drafts mental health generative AI guidance. Excerpted from Pathways Picks October 7: AI Plans in the UK and US, Europe’s First JCA Devices, and More.