Becker's Hospital Review - FDA clears Eko's AI-powered stethoscope for AFib, heart murmur detection

Andrea Park

January 28, 2020

Eko has received FDA clearance for two artificial intelligence algorithms embedded into the healthcare technology company's digital stethoscope to detect serious heart conditions, the company announced Jan. 28.

Eko DUO stethoscopes equipped with the two algorithms and a single-lead ECG have been found in clinical studies to detect atrial fibrillation with 99 percent sensitivity and 97 percent specificity, and heart murmurs with 87 percent sensitivity and 87 percent specificity.

The AI-powered stethoscope offers significant improvements over traditional stethoscopes, allowing physicians to more quickly and accurately identify and treat the heart conditions, which can lead to stroke and heart failure if undiagnosed.

"Two centuries after its invention, the stethoscope is still the frontline tool to detect cardiovascular disease," Patrick McCarthy, MD, executive director of Chicago-based Northwestern Medicine's Bluhm Cardiovascular Institute and a member of Eko's Scientific Advisory Board, said in the announcement. "Eko's development of artificial intelligence algorithms to help clinicians better interpret sounds, identify arrhythmias and detect heart murmurs during a physical exam is going to make a huge difference in our ability to care for patients."

Another algorithm developed by Eko and Rochester, Minn.-based Mayo Clinic to detect reduced left ventricular ejection fraction has not yet been cleared by the FDA, but received "breakthrough device" designation from the agency in December 2019.

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