FDA marketing authorizations for AI-powered medical tools have passed the 1,500 mark. The agency’s public tracking list shows cancer applications among the fastest-growing entries.
The agency’s AI-Enabled Medical Devices List spans both hardware and software. Entries arrive through 510(k) clearances, De Novo authorizations and Premarket Approvals. The FDA updates the list periodically as it identifies new devices, and officials stress it is not comprehensive.
Roughly 97 percent of authorizations came in the last decade and 68 percent since 2022, according to BioSpace’s analysis. Radiology accounts for 76 percent of approved devices, followed by cardiovascular at 10 percent and neurology at 4 percent.
Recent oncology entries include Perimeter Medical Imaging AI’s Claire OCT system, which won PMA in March for flagging suspicious areas in breast lumpectomy tissue, and RevealDx’s RevealAI-Lung, cleared in January to score cancer risk in lung CT nodules. Earlier milestones range from Artera’s ArteraAI Prostate to MD Anderson’s Radiation Planning Assistant and Paige Prostate for digital pathology.
The sheer scale signals how deeply AI has moved into cancer detection, diagnosis and treatment planning, and how oversight will have to evolve as models grow more capable. Critics counter that clearance is not proof of clinical benefit, and the FDA continues to develop its approach to adaptive and generative systems even as the count climbs.
