HeartSciences Inc. is a medical technology company dedicated to augmenting the clinical utility of electrocardiograms (ECGs) by integrating artificial intelligence (AI). The firm develops AI-enhanced ECG (AI-ECG) solutions, including an algorithm specifically designed to detect impaired cardiac relaxation or other forms of cardiac dysfunction, whether caused by heart disease or the natural aging process. Among its offerings is the MyoVista wavECG device, a 12-lead resting ECG that provides comprehensive diagnostic information concerning cardiac function alongside conventional ECG data in a single examination. Furthermore, the company offers MyoVista Insights, a cloud-based platform capable of hosting its AI-ECG algorithms across various ECG hardware systems. Established in 2007, HeartSciences Inc. operates from its headquarters in Southlake, Texas. The company was formerly named Heart Test Laboratories, Inc. until its rebranding to HeartSciences Inc. in October 2024.
HeartSciences Receives FDA 510(k) Clearance for its MyoVista® wavECGTM Device
HeartSciences received FDA 510(k) clearance (K260005) for its MyoVista wavECG device as a 12-lead resting electrocardiograph for adult and pediatric use in hospitals and healthcare facilities.
The clearance does not include the company's AI-ECG algorithm, and HeartSciences says it does not intend to commercialize the device without a cleared algorithm and has no timeline for commercialization; clearance mainly broadens options for realizing value from the device and its IP.
Separately, the proposed business combination with Fortitude Mining Holdings, currently wholly-owned by Digital Currency Group, remains on track to close in Q4 calendar 2026, subject to HeartSciences shareholder approval.