REGULATION · US
FDA final order: radiology AI models must clear premarket review before revenue
FDA rule effective 2026-09-17 requires AI-enabled radiology software (multiple categories) to obtain premarket clearance before generating revenue in the US. Gate remains in place despite fintech/healthtech pressure to streamline.
WHY IT MATTERS
Explicit FDA stance that AI medical devices = regulated medical devices, blocking monetization until proof of safety/efficacy. Sets template for all medical AI; delays revenue by 6–18 months; pushes cost to vendor (not hospital).
Source: PYMNTS · 2026-09-17