FDA refuses to exempt radiology AI software from 510(k) review
On April 1, 2026, the FDA denied a petition from Sydney-based Harrison.ai. The company wanted developers that already had a 510(k) clearance to be able to market new AI tools in four radiology categories without premarket review, including triage (CADt), detection and diagnosis (CADe/CADx) software and medical image analyzers. The agency said clearing one device does not show that a company's processes will produce safe future devices, and that postmarket monitoring cannot replace premarket review. It pointed developers to predetermined change control plans instead. The FDA finalized the denial in the Federal Register on September 17, 2026.
Why it's notable: New radiology AI tools, and major new versions of them, will still need FDA review before they reach health systems. Buyers should check which software version is actually cleared.