FDA Sets New Rules for AI Software That Flags Possible Heart Conditions

Artificial intelligence is increasingly being incorporated into cardiovascular care, but the FDA says cardiovascular machine learning-based notification software is intended to flag the likelihood of a condition for further evaluation—not provide a final diagnosis. The agency has formally classified the technology as a Class II medical device subject to special controls. Satyrenko/Shutterstock

Artificial intelligence is increasingly being used to help doctors identify patients who may need additional testing for heart conditions, and the Food and Drug Administration has now formally established how one category of that technology will be regulated.

The FDA issued a final order classifying “cardiovascular machine learning-based notification software” as a Class II medical device subject to special controls. The order took effect September 11, 2026, although the underlying classification has applied since August 3, 2023.