HeartSciences Receives FDA Clearance for MyoVista® wavECG™ Device

Southlake, TX, Oct. 06, 2026 /CourierPR/ -- HeartSciences Inc., a healthcare information technology company focused on advancing electrocardiography through the integration of artificial intelligence, has received FDA 510(k) clearance for its MyoVista® wavECG™ device. The clearance, granted under FDA clearance number K260005, allows the device to be used as a 12-lead resting electrocardiograph for adult and pediatric patients in hospitals and healthcare facilities. The device provides interpretive statements to clinicians on an advisory basis.

This development comes as HeartSciences continues to progress with its proposed business combination with Fortitude Mining Holdings, Inc., announced in June 2026. The company expects to close the transaction in the fourth quarter of 2026, subject to customary closing conditions, including approval by HeartSciences’ shareholders.

HeartSciences’ CEO, Andrew Simpson, expressed gratitude to the clinical, regulatory, and engineering teams for their efforts in achieving this clearance.

The MyoVista® wavECG™ device is part of HeartSciences’ broader strategy to modernize electrocardiography workflows and improve clinical efficiency and decision-making. The company’s MyoVista Insights™ Platform is a cloud-native, vendor- and device-agnostic ECG management system designed to integrate with existing ECG equipment and deliver AI-ECG algorithms into clinical workflows.

HeartSciences has previously 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. 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, however, broadens the potential options available to the company for the device and its related intellectual property, which the company intends to evaluate.

HeartSciences’ 2026 Annual Report on Form 10-K, filed with the SEC on July 23, 2026, and its Quarterly Report for the fiscal quarter ended July 31, 2026, provide additional details on the company’s financial and operational status. The reports are available on the SEC’s website and can be accessed by interested parties.

The proposed transaction with Fortitude continues to progress, with the company expecting to close the deal in the fourth quarter of 2026. HeartSciences has filed a preliminary proxy statement on Schedule 14A with the SEC, which will be followed by a definitive proxy statement when it becomes available. Shareholders are encouraged to review these documents for more information on the proposed business combination.