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FDA Issues EUA for Eko’s ECG-based Low Ejection Fraction Screening Algorithm

Awarded an FDA Breakthrough Device designation in December 2019, the algorithm’s regulatory review has been further accelerated due to its potential to assist providers in identifying patients with abnormal heart function during the COVID-19 pandemic.

FDA Grants ‘Breakthrough’ Designation to Eko’s ECG-based Low Ejection Fraction Screening Algorithm, Designed to Improve Detection of Heart Failure

The algorithm analyzes 15 seconds of ECG data collected from the Eko DUO digital stethoscope during a physical exam and helps identify reduced Left Ventricular Ejection Fraction (LVEF), a measure commonly used to diagnose patients with heart failure.