Powerful Medical’s “Queen of Hearts” AI ECG Model Wins FDA De Novo Nod

AI-driven cardiovascular diagnostics company Powerful Medical has earned U.S. Food and Drug Administration (FDA) De Novo authorization for its Queen of Hearts ACS AI ECG Model.

The AI model identifies ECG findings indicative of urgent acute coronary syndrome (ACS), including ST-segment elevation myocardial infarction (STEMI) and equivalents, and alerts clinicians to suspected cases.

Although ECG is the primary diagnostic tool, standard interpretation can miss acute heart attacks, particularly STEMI equivalents, delaying treatment. In Europe, Queen of Hearts detected over 120,000 heart attacks in 2025 following CE marking, helping reduce treatment times in more than half of cases.

Following Breakthrough Device Designation in March 2025 and inclusion in the FDA’s Total Product Life Cycle Advisory Program (TAP), Powerful Medical now establishes a new device classification for AI-based ECG models targeting acute, life-threatening cardiovascular conditions.

Queen of Hearts is supported by over 20 peer-reviewed studies, including randomized controlled trials involving over 40,000 patients across four continents. Published data shows roughly twice the sensitivity of standard care, up to fivefold fewer false positives, and faster treatment, supporting earlier identification of suspected ACS patients who might benefit from cardiology consultation and cardiac catheterization.

Now that it’s won the De Novo nod, the New York-based company is accelerating U.S. deployment of PMcardio, an AI-driven cardiac care platform that integrates ECG interpretation across prehospital, emergency and cardiology environments. The platform embeds AI ECG modules into clinical workflows, supporting assessment at first contact and handoff to cardiology to reduce time to reperfusion and improve outcomes.

Comments from Powerful Medical execs

Martin Herman, founder and CEO: “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.”

Robert Herman, MD, Ph.D., co-founder and chief medical officer: “Many heart attack patients in the United States still miss the window for life-saving treatment due to delays in diagnosis and inefficient triage.”

Felix Bauer, co-founder and COO: “With FDA approved technology now available, we can bridge this gap by bringing accurate, real-time ECG interpretation to the first medical contact.”