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StableMarketsReported 2026-10-06 20:30

HeartSciences Receives FDA 510(k) Clearance for MyoVista® wavECG Device

HeartSciences Inc. received FDA 510(k) clearance for its MyoVista® wavECG device, allowing it to be used for 12-lead resting ECG in hospitals and healthcare facilities. The clearance does not include an AI-ECG algorithm, and the company plans to evaluate its options for commercialization.

Why it matters. HeartSciences' device can now be used in clinical settings, potentially improving ECG workflows and clinical decision-making.

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Evidence

  • GGlobeNewswire public company newsCompany2026-10-06 20:30
    the recoverability of the related inventory
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  • GGlobeNewswire public company newsCompany2026-10-06 20:30
    HeartSciences’ amended preliminary proxy statement on Schedule 14A, filed with the U.S. Securities and Exchange Commission (the “SEC”) on October 6, 2026, in connection with the Proposed Transaction (the “Preliminary Proxy Statement”)
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  • GGlobeNewswire public company newsCompany2026-10-06 20:30
    HeartSciences is a healthcare information technology company advancing the use of ECG/EKGs through the integration of artificial intelligence.
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  • GGlobeNewswire public company newsCompany2026-10-06 20:30
    HeartSciences’ MyoVista Insights™ Platform is a cloud-native, vendor- and device-agnostic ECG management system designed to modernize ECG workflows and improve clinical efficiency and decision-making.
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  • GGlobeNewswire public company newsCompany2026-10-06 20:30
    The proposed business combination with Fortitude Mining Holdings, Inc. (“Fortitude”), announced in June 2026 (the “Proposed Transaction”), continues to progress.
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  • GGlobeNewswire public company newsCompany2026-10-06 20:30
    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 d…
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  • GGlobeNewswire public company newsCompany2026-10-06 20:30
    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 health…
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