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BioWorld - Tuesday, June 23, 2026
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Home » Eko scores FDA breakthrough status for ECG-based algorithm
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Eko scores FDA breakthrough status for ECG-based algorithm

Dec. 18, 2019
By Meg Bryant
Heart failure is a leading cause of disability and death in the U.S., but many cases are diagnosed late due to limited access to echocardiography, the primary method of detecting the condition. To address that need, the U.S. FDA has granted breakthrough device designation to Eko Devices Inc., of Berkeley, Calif., for an electrocardiogram (ECG)-based algorithm that could serve as an easily accessible screening tool for heart failure during routine physical exams.
Medical technology Regulatory Artificial intelligence Digital health Cardiovascular FDA

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