HeartSciences wins FDA 510(k) clearance for MyoVista wavECG device
HSCS•HeartSciences received FDA 510(k) clearance for MyoVista wavECG as a 12-lead resting electrocardiograph, but the authorization excludes its AI-ECG algorithm and the company has no commercialization timeline.
1. FDA clearance
The clearance covers ECG acquisition and interpretation for adult and pediatric patients in hospitals and healthcare facilities. It does not include the AI-ECG algorithm, and HeartSciences has no timeline to commercialize the device.
