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

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

The company said this approval marks a milestone in the early detection of heart disease. Traditional heart failure detection methods, such as echocardiography, are often not available in primary care settings. This means that many early-stage cases are not diagnosed until symptoms worsen and the person visits the hospital.

“The ability to identify potentially life-threatening hidden cardiac conditions using a stethoscope, a familiar tool for primary care physicians and subspecialist clinicians, can help prevent hospitalizations and adverse events.” said Paul Friedman, M.D., chief of cardiovascular medicine. Mayo Clinic said in an April 2 news release. “Importantly, because the stethoscope is small and portable, we hope this technology can be used in urban and remote areas, contributing to care in underserved areas.”

More than 6 million people nationwide suffer from heart failure, and about half of them have low EF.

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