Eko’s Murmur Analysis Software Gets 510(k) Clearance

Eko’s artificial intelligence-based Eko Murmur Analysis Software (EMAS) has received 510(k) clearance from the FDA for detecting heart disease.

The software, which uses a cloud-based machine learning algorithm that analyzes heart sounds, phonocardiogram and electrocardiogram (ECG) signals from Eko’s smart stethoscopes, can differentiate between innocent and structural heart murmurs and detect valvular heart disease. 

Combining murmur analysis AI with digital stethoscopes transforms the traditional stethoscope into a low-cost screening tool that “can identify significant structural heart disease in seconds,” the Oakland, Calif.-based company said.

The database used in the training and testing of EMAS is “one of the world's largest repositories of clinically validated heart sounds,” Eko said.