This episode examines HeartLung Corporation’s FDA five ten k clearance for opportunistic cardiovascular risk extraction from routine CT scans, Utah’s regulatory sandbox authorizing AI driven prescription refills for one hundred ninety medications under physician review, and the FDA’s new flexibility for cell and gene therapy manufacturing quality requirements. The briefing covers implementation costs between three hundred thousand and five hundred thousand dollars per algorithm, clarifies enforcement discretion for low risk clinical decision support tools, and reviews how regulatory frameworks are shaping deployment economics across health systems with varying institutional resources.
