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In this week’s Pathways Picks: A report from The MedTech Conference in Boston, including insights from FDA, CMS, AMA, EU, and UK officials. Updates on CDRH hiring efforts, EU reform timelines, AI policy moves in the US, UK, and EU, perspectives on the impending FDA-CMS RAPID program, and more from around the world.
In this month's news, 510(k)s for several AI image analysis tools, Steris buys Xodus Medical for $2.1 billion, developments in the Delphi and READI-Home programs for patient-used products, and more.
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.