FDA gives emergency authorization to Mayo-backed digital tool to detect weak heart

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A Mayo-developed digital health company received the FDA's emergency use authorization for an algorithm that can detect heart failure in users.

Eko's ECG-based algorithm screens for a weak heart pump, which is a comorbidity for COVID-19 patients; coronavirus patients with cardiovascular disease have a case fatality rate of 10.5 percent, according to American College of Cardiology estimates.

The device received the FDA's Breakthrough Device designation in December and its regulatory review was accelerated during the pandemic. Mayo Clinic has begun using the device to screen patients for cardiovascular disease.

Mayo Clinic has financial interest in the technology and reported it will use associated revenue to support patient care, education and research at the system.

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