Eko receives FDA clearance for AF and heart murmur algorithms

Eko’s AI is a cloud-based software application that analyses ECG and heart sound/phonocardiogram (PCG) data

Eko has announced that the US Food and Drug Administration (FDA) has cleared a suite of algorithms that, when combined with Eko’s digital stethoscopes, will enable healthcare providers to more accurately screen for heart conditions during routine physical exams.

Eko’s atrial fibrillation (AF) 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 echocardiogram (ECG) based algorithm that, if FDA-cleared, could provide an easily accessible screening test for heart failure, the company said in a press release. 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 US and Europe.

Eko’s AI is a cloud-based software application that analyses 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 analyses simultaneous ECG and heart sounds and will detect the presence of suspected murmurs in the heart sounds as well as the presence of AF and normal sinus rhythm from the ECG signal.

“Our vision since day one has been to build seamless technology that helps providers more accurately detect heart disease, the leading killer in the world, by putting the ears of a cardiologist in any clinician’s stethoscope,” says Connor Landgraf, Eko’s co-founder and CEO. “Eko’s new ability to alert a provider to the presence of a heart murmur or atrial fibrillation during the standard physical exam brings that vision to life.”


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