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

Southlake, TX — HeartSciences Inc. (Nasdaq: HSCS / HSCSW) 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 platform capable of hosting AI-ECG algorithm(s). Following the recent publication of updated American Society of Echocardiography (ASE) guidelines for the assessment of Left Ventricular Diastolic Dysfunction, including revised age-based thresholds for cardiac relaxation (e'), the company elected to separate the FDA submissions for the device and its impaired cardiac relaxation AI-ECG software algorithm. This approach simplifies the regulatory pathway and accelerates clearance of the device, while preserving flexibility to deploy the AI-ECG algorithm across both wavECG and the MyoVista Insights HIT software platform.

"The FDA submission of the MyoVista wavECG device represents an important regulatory milestone as we advance our commercialization strategy," said Andrew Simpson, CEO of HeartSciences. "In parallel, we continue to make meaningful progress with MyoVista Insights, our ECG reporting and management platform, and are engaged in commercial discussions with several healthcare institutions."