Eko, a digital health company building AI-powered screening and telehealth solutions to fight cardiovascular disease, today announced that the U.S. Food and Drug Administration (FDA) has issued the company an Emergency Use Authorization (EUA) for its novel ECG-based algorithm that can provide an easily accessible, rapid screening test for low ejection fraction (low EF), a weak heart pump.
“Early detection of heart failure patients can better inform treatments for these individuals at higher risk for severe illness from COVID-19”Tweet this
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.
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