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Did FDA clear a product that incorporates a large language model? Excerpted from Pathways’ Picks July 1: FDA Clears an LLM? Asia Updates, Ireland’s Elevation, and More.
FDA provides more details on the draft MDUFA VI agreement. Excerpted from Pathways Picks July 15: America First" Fees, Remote Monitoring Restrictions, Aussie Advertising Code, and More.
Industry and hospital groups call out CMS for tightening its proposed coverage policy language for transcatheter aortic valve replacements. Excerpted from Pathways Picks July 23: TEMPO Selection, TAVR Coverage, AI Picks, and India’s Software Guidance.
CMS reiterates its plan to cancel the streamlined path. Excerpted from Pathways’ Picks June 8: MDUFA Agreement, Medicare Plans, EU Parliament Response, and More.