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.
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