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This episode covers the FDA’s February seventeenth clearance of Copan’s PhenoMATRIX software for AI-assisted bacterial culture plate sorting across multiple media types, Medtronic’s Stealth AXiS platform integrating AI-driven planning and navigation for spine procedures, and the ninety percent Phase I success rate of drug candidates generated through generative AI platforms. It also examines a UC San Diego large language model workflow achieving ninety-nine percent accuracy in colorectal cancer risk prediction for ulcerative colitis patients, and the FDA’s recent pattern of issuing complete response letters to applications meeting predefined endpoints, affecting sponsor valuation models and development strategy. Listeners gain insight into regulatory pathways for diagnostic and surgical AI, computational drug development economics, and evolving benefit-risk frameworks shaping late-stage clinical programs.