AI-Powered ECG Model Gains FDA Authorization for Emergency Cardiac Assessment

S. Food and Drug Administration (FDA) De Novo authorization, announced on September 15, 2026. The model is designed to identify electrocardiogram findings suggestive of urgent acute coronary syndrome (ACS), including ST‑segment elevation myocardial infarction (STEMI) and STEMI equivalents, and to rapidly alert clinicians. The company reports prior deployment in Europe following CE‑marking.

The system analyzes 12‑lead electrocardiograms to flag patterns consistent with life‑threatening coronary occlusion that warrant urgent cardiologist review. Within the PMcardio platform, Queen of Hearts is embedded into existing pre‑hospital, emergency department, and cardiology workflows to support early identification, cardiology consultation, and early cardiac catheterization. The platform is positioned as a care‑coordination layer that carries algorithmic assessment from first medical contact through specialty handoff.

Regulatory clearance via the De Novo pathway establishes a new device classification for AI electrocardiography models that address acute, life‑threatening cardiovascular diagnoses. The authorization follows Breakthrough Device Designation in March 2025 and participation in the Food and Drug Administration’s Total Product Life Cycle Advisory Program. The company indicates it is accelerating U.S. deployment within health systems.

According to the announcement, Queen of Hearts is supported by more than 20 peer‑reviewed studies, including randomized controlled trials across over 40,000 patients on four continents. Published data cited by the company show approximately twofold higher sensitivity than standard of care, up to fivefold fewer false positives, and faster time to treatment. The firm also reports that European use detected more than 120,000 heart attacks in 2025, with reduced treatment times in over half of these cases.

“This milestone reflects our mission to ensure every patient has access to fast, accurate heart attack diagnosis, regardless of where they present. With FDA De Novo authorization in place, we can scale adoption and bring this technology into routine clinical care across the United States,” said Martin Herman, CEO and Co‑founder of Powerful Medical.

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