This episode examines the FDA’s policy shift allowing clinical decision support software to bypass premarket review, the convergence of three regulatory deadlines in February 2026 that impose manufacturer-grade compliance on radiology groups customizing AI workflows, and new clearances for RapidAI’s neurovascular imaging modules, BrainSpace’s adaptive hydrocephalus management system, and UltraSight’s multi-platform cardiac ultrasound program. The briefing details how HTI-1 transparency requirements, ISO 13485 quality management standards, and Recovery Audit Contractor enforcement are reshaping operational accountability for health systems deploying AI-enabled clinical interventions.
