HeartSciences Inc. (NASDAQ:HSCS, HSCSW))) ("HeartSciences" or the "Company"), a healthcare information technology ("HIT") company focused on advancing electrocardiography ("ECG" or "EKG") through the integration of artificial intelligence ("AI"), today announced that the U.S. Food and Drug Administration ("FDA") has granted 510(k) clearance (K260005) for its MyoVista® wavECGTM device as a 12-lead resting electrocardiograph. The clearance covers the acquisition and interpretation of ECG signals from adult and pediatric patients in hospitals and healthcare facilities, with interpretive statements provided to clinicians on an advisory basis. The clearance does not include an AI-ECG algorithm.

As previously reported, HeartSciences separated the FDA submissions for the MyoVista wavECG device and its impaired cardiac relaxation AI-ECG algorithm following updated guidance published by the American Society of Echocardiography regarding the assessment of left ventricular diastolic dysfunction. The Company does not intend to commercialize the device without a cleared AI-ECG algorithm and has made no commitment to, and has no timeline for, commercialization of the device. The clearance does, however, broaden the potential options available to the Company for the device and its related intellectual property, which the Company intends to evaluate.