5 takeaways from the FDA’s updated list of cleared AI/ML medical devices

MedTech Dive October 24, 2023
Elise Reuter

The agency recently added 171 new devices to its list, with radiology once again accounting for the most authorizations.

A growing number of medical devices include artificial intelligence or machine learning features, and the Food and Drug Administration has started tracking ones that have gone through the agency’s approval. The FDA recently updated its list of AI/ML-enabled devices, showing that nearly 700 have now received marketing authorization.

The latest update added a total of 171 new devices, the majority of which were cleared between August 2022 and July 2023.

Last year, when the FDA first unveiled the list, MedTech Dive found that the majority of cleared AI/ML devices were used in radiology and went through the agency’s 510(k)...

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