STAT+: FDA clears digital stethoscope company’s AI algorithm for heart failure
An AI algorithm to detect heart failure, embedded in a digital stethoscope, earned clearance from the Food and Drug Administration on Tuesday. The goal is to help primary care doctors more easily identify the often-hidden condition.
The stethoscope is the result of a collaboration between Mayo Clinic researchers, who built the algorithm, and the startup Eko Health, which built the hardware. Mayo Clinic is an investor in Eko, which has raised $128 million over the past six years. Eko’s stethoscopes currently use two predictive AI algorithms: one for atrial fibrillation and one for structural heart murmur. The difference with heart failure, though, is how much more difficult it is for doctors to catch.
Nearly 6.5 million Americans have heart failure, meaning their hearts are unable to pump blood properly. The illness is typically visible via heart ultrasounds, or echocardiograms, but these tests are expensive. Catching the condition early and non-invasively at a primary care checkup could save lives.
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