HeartSciences Submits MyoVista wavECG Device for FDA Clearance

HeartSciences has submitted its MyoVista wavECG device to the FDA for 510(k) premarket clearance. The device is designed to provide conventional ECG functionality and host AI-ECG algorithm(s). The Company elected to separate the FDA submissions for the device and its impaired cardiac relaxation AI-ECG software algorithm to simplify the regulatory pathway and accelerate clearance of the device. This strategy preserves flexibility for future deployment of the AI-ECG algorithm across both the MyoVista wavECG device and the Company's MyoVista Insights HIT software platform.