Mayo Clinic partner Eko earns FDA 'breakthrough device' designation

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An artificial intelligence algorithm developed by Rochester, Minn.-based Mayo Clinic and cardiac monitoring startup Eko to analyze ECG data for evidence of reduced left ventricular ejection fraction has been designated a "breakthrough device" by the FDA.

The algorithm reads ECG data collected by Eko's digital stethoscope to measure LVEF, which refers to the amount of blood pumped out of the heart's left ventricle and can indicate heart failure. The breakthrough device label, presented to technology with potential to address unmet clinical needs, will speed up regulatory review of the algorithm.

Eko and Mayo Clinic's partnership to develop the AI algorithm began in late 2018. Since then, studies have shown that the algorithm-equipped stethoscope achieves significant accuracy in detecting low ejection fraction. Mayo Clinic also joined Eko's $20 million Series B funding round in September to advance the startup's research.

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