Eko secures FDA clearance for heart disease detection software

Digital health company Eko has received US Food and Drug Administration (FDA) clearance for its Cloud-based machine learning algorithm Eko Murmur Analysis Software (EMAS).

The software characterises heart murmurs by assessing heart sounds, phonocardiogram and ECG signals (when available) captured using Eko’s smart stethoscopes.

This characterisation would help healthcare professionals identify structural heart murmurs, which are indicative of valvular heart disease.

According to the company, the use of the EMAS algorithm enables healthcare professionals to identify valvular heart disease with an overall sensitivity of 85.6% and specificity of 84.4%.

The figures further improve to 90.2% and specificity of 90.6% for adults 18 years and older.

In comparison, general practitioners (GPs) demonstrated a sensitivity of 44% and specificity of 69% for detecting significant valvular heart disease using traditional stethoscopes.

Eko co-founder and CEO Connor Landgraf said: “This latest FDA clearance is another way in which Eko is improving access to better heart health through clinically-validated algorithms and best-in-class medical devices.

“By making heart disease screening algorithms and digital stethoscopes accessible in exam rooms around the country, we are moving towards a future in which more objective and consistent valvular heart disease screening can become the standard of care.”

Around 2.5% of the US population suffers from valvular heart disease, according to data from the Centers for Disease Control and Prevention (CDC).

Eko expects the use of murmur analysis artificial intelligence (AI) and digital stethoscopes to reduce the time taken to detect significant structural heart disease on the front lines of care to just seconds. Medical Device Network