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| 1 minute read

FDA posts new resource for locating approved AI/ML-enabled medical devices

The U.S. Food and Drug Administration (FDA) has begun to gather and publish a list of medical devices that are enabled through software incorporating artificial intelligence (AI) – specifically the subset of AI known as machine learning (ML) – and that have been authorized by FDA to be marketed.

The FDA notes that for the past decade, it has reviewed and authorized a growing number of devices with ML across many different fields of medicine. These devices are now legally marketed after the FDA's scientific and regulatory approval [via 510(k) clearance, granted De Novo request, or via premarket approval (PMA)]. The FDA expects this trend to continue.

The FDA says it is publishing the list of AI/ML-enabled medical devices marketed in the United States as a resource to the public about these devices and the FDA’s work in this area. The listing displays the approval, authorization, or clearance information for each AI/ML-enabled device with links to the FDA's publicly available information.

The list is comprehensive. There are approximately 350 AI/ML-enabled devices authorized by FDA on the list, with some approvals going back decades. The first device listed had its authorization date in 1997. The vast majority of the authorized devices are in the radiology space.

The FDA plans to update the list on an ongoing basis.

This initial list contains publicly available information on AI/ML-enabled devices.


health care & life sciences, fda, artificial intelligence, ai, machine learning, ml