HeartSciences Announces FDA 510(k) Submission for MyoVista® wavECG™ Device

Southlake, TX, Dec. 15, 2025 (GLOBE NEWSWIRE) -- HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”) company advancing the use of ECG/EKGs through the integration of artificial intelligence (“AI”), today announced it has submitted its MyoVista® wavECG™ device to the U.S. Food and Drug Administration (“FDA”) for 510(k) premarket clearance. The MyoVista wavECG device is designed to provide conventional ECG functionality while serving as a pl ...