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In this week’s Pathways Picks: Did FDA clear the first 510(k) for a large language model? South Korea advances its AI guidelines; India proposes accelerated review timelines; updates from Malaysia and China; Rep. Diana DeGette defeated; FDA signals end to COVID EUAs; TAP is open to all device types; Ireland ascends to Council presidency; and more global medtech policy news.
Discussions about AI’s impact on healthcare often focus on drug discovery, healthcare system operational efficiencies, and clinical decision support for physicians. A conference organized by the New York Academy of Sciences and the Icahn School of Medicine at Mount Sinai also included talks by executives from major AI companies NVIDIA and Microsoft on their research strategies, including important initiatives involving medical device manufacturers.
FDA plans to exempt more unclassified devices from premarket notification requirements. Excerpted from Pathways’ Picks June 11: Opposition to EU WET Exemptions, Medicare Coverage Updates, and More.