This episode examines the FDA’s formal public comment period on a citizen petition requesting conditional 510(k) exemption for radiology AI devices, comparing U.S. finding-by-finding clearance requirements against international multi-finding approval pathways. Coverage includes December oncology regulatory activity, featuring traditional approval conversions for pirtobrutinib and rucaparib, first-in-indication CAR-T approval for marginal zone lymphoma, and breakthrough therapy designations for HER2-targeted therapies. The briefing also covers the FDA’s first qualification of an AI-based drug development tool for MASH trials, CapsoVision’s PMA submission for AI-powered capsule endoscopy, and the progression of imaging systems into multimodal clinical integration platforms supporting precision medicine workflows.
