The FDA finalized an order on September 17, 2026, requiring AI-enabled radiology software to continue obtaining premarket clearance before entering the market, rejecting a petition from healthcare AI company Harrison.ai for a partial exemption. Manufacturers must keep submitting 510(k) applications showing substantial equivalence to already-cleared devices rather than relying solely on post-market monitoring. The decision carries financial implications for radiology AI vendors and health systems tracking which product versions carry FDA authorization.
