FDA clears 1st AI to detect heart failure

The FDA has approved an artificial intelligence algorithm for Eko Health's digital stethoscope that can detect low ejection fraction, a key indicator of heart failure.

Eko Health developed the algorithm with Rochester, Minn.-based Mayo Clinic. The AI stethoscope will allow clinicians to detect low EF — when the heart does not efficiently pump blood — in about 15 seconds during routine exams.

The approval represents a milestone in the early detection of heart disease, the company said. Traditional heart failure detection methods, such as echocardiography, are often unavailable in primary care settings. This means many early-stage cases go undiagnosed until symptoms worsen and result in hospital visits.

"The ability to identify a hidden, potentially life-threatening heart condition using a tool that primary care and subspecialist clinicians are familiar with — the stethoscope — can help us prevent hospitalizations and adverse events," Paul Friedman, MD, chair of cardiovascular medicine at Mayo Clinic, said in an April 2 news release. "Importantly, since a stethoscope is small and portable, this technology can be used in urban and remote locations, and hopefully help address care in underserved areas."

Heart failure affects more than 6 million people nationwide, about half of whom have low EF. 

Learn more here.

Copyright © 2025 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


You can unsubscribe from these communications at any time. For more information, please review our Privacy Policy
.
 

Articles We Think You'll Like