FDA Grants Breakthrough Designation to Ekos ECG-based Low Ejection Fraction Screening Algorithm

December 19, 2019 — The U.S. Food and Drug Administration (FDA) has granted breakthrough status for a novel ECG-based algorithm that could provide an easily accessible screening test for heart failure. Developed by Eko, a digital health company applying artificial intelligence (AI) in heart disease, the algorithm analyzes 15 seconds of ECG data collected from the Eko Duo digital stethoscope. The…

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