HeartSciences Receives FDA Clearance for MyoVista wavECG Device

Key Facts

1HeartSciences received FDA 510(k) clearance for its MyoVista wavECG device as a 12-lead resting electrocardiograph.

HeartSciences received FDA 510(k) clearance for its MyoVista wavECG device as a 12-lead resting electrocardiograph. GlobeNewswire reported that the clearance allows the device, which integrates artificial intelligence, to be used for acquiring and interpreting ECG signals from adult and pediatric patients in hospitals and healthcare facilities.

HSCS closed at $4.36 on October 5, 2026, with the stock reaching a session high of $4.63 and a low of $4.15. This regulatory milestone represents a major step for the company in commercializing its advanced electrocardiography technology and entering medical markets.