FDA Output
FDA Output, June 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in June 2026. Updated June 30.
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Business Strategies
The Nuts and Bolts of Artificial Intelligence in Medtech
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.
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Pathways’ Pick of the Week
Pathways' Pick of the Week: Bypassing 510(k)s
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.