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FDA clears Eko’s AFib and heart murmur detection algorithms

Press releases may be edited for formatting or style | January 28, 2020 Artificial Intelligence Cardiology

Eko’s AFib and Murmur screening algorithms are the first in a suite of cardiac screening algorithms Eko plans to combine with its digital stethoscope devices to assist providers in the detection of cardiovascular conditions. In December 2019, Eko announced the FDA had granted the company breakthrough status for a novel ECG-based algorithm that, if FDA-cleared, could provide an easily accessible screening test for heart failure. Since the release of its first-generation Eko CORE device in 2015, Eko’s technology has been adopted by clinicians at more than 4,000 hospitals and clinics in the U.S. and Europe.


About Eko’s AI
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Eko’s AI is a cloud-based software application that analyzes ECG and heart sound/phonocardiogram (PCG) data. The software uses several methods to interpret the acquired signals, including signal processing and convolutional neural networks.

The software is intended to provide support to the physician in the evaluation of patients' heart sounds and ECGs. The software analyzes simultaneous ECG and heart sounds and will detect the presence of suspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normal sinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRS duration and electromechanical activation time (EMAT). The software does not distinguish between different kinds of murmurs and does not identify other arrhythmias.

Eko’s AI is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software are only significant when used in conjunction with physician over-read and when used on adults (> 18 years).


About Eko
Eko is driving the next evolution in cardiac care by creating digital health solutions that enable doctors, nurses and entire health systems to change how we care for the heart. Eko brings together advanced stethoscopes, patient and provider software, and AI-powered analysis—elevating the way clinicians detect and monitor cardiovascular disease. Its FDA cleared platform is used by thousands of clinicians treating tens of millions of patients around the world. Eko is a privately-held company headquartered in Berkeley, California.

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