HeartSciences Receives FDA 510(k) Clearance for its MyoVista® wavECGTM Device
Key Highlights
- ➤FDA grants 510(k) clearance for MyoVista wavECG as a 12-lead resting electrocardiograph
- ➤Clearance covers adult and pediatric ECG acquisition and advisory interpretation in healthcare facilities
- ➤Device clearance excludes HeartSciences’ impaired cardiac relaxation AI-ECG algorithm
- ➤HeartSciences will not commercialize wavECG without an AI-ECG clearance or commercialization timeline
- ➤Fortitude transaction expected to close in Q4 calendar 2026, pending shareholder approval
Expert Statements
Andrew Simpson, CEO of HeartSciences
“This clearance is the result of several years of work by our clinical, regulatory and engineering teams, and I want to thank them for the quality and persistence of that effort.”
Andrew Simpson, CEO of HeartSciences
“Our commercial focus remains on MyoVista Insights, but clearance makes the device and the intellectual property behind it a more readily realizable asset, and we will take the time to consider the best route to realizing that value.”
Southlake, TX, Oct. 06, 2026 (GLOBE NEWSWIRE) -- 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® wavECG(TM) 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.
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