Radiology Business

Radiology Artificial Intelligence Firm Asks FDA to Exempt Certain Devices From Premarket Review

Harrison.ai filed a citizen petition asking the FDA to grant optional pre‑market exemption for radiology computer‑aided detection (CAD) devices, allowing manufacturers with an existing cleared product to launch similar tools without a new 510(k). The agency must issue a rapid final order, and the proposal would replace traditional review with post‑market performance monitoring and mandatory training for users. The petition has drawn sharp criticism from the RSNA, patient groups, and some AI vendors who warn of safety risks, while other vendors such as Lunit and Quibim back the move for faster innovation and lower costs. A decision is expected within months.