Powerful Medical Receives FDA De Novo Approval for PMcardio “Queen of Hearts,” Its AI ECG Model for Detecting Acute Heart Attacks

World’s first FDA authorization for an AI ECG solution designed to detect acute heart attacks requiring urgent cardiologist review, enabling scalable deployment across U.S. health systems

New York, United States – September 15, 2026 – Powerful Medical, a leader in AI-driven cardiovascular diagnostics, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for Queen of Hearts (ACS AI ECG Model). The AI-powered model is designed to identify ECG findings suggestive of urgent acute coronary syndrome (ACS), which can include ST-segment elevation myocardial infarction (STEMI) and STEMI equivalents, and urgently notify clinicians of suspected cases.

Heart attacks remain a leading cause of death, with patients in the United States affected every 40 seconds. Rapid diagnosis is critical to improving survival. While the electrocardiogram (ECG) is the primary diagnostic tool, standard-of-care interpretation often fails to detect a significant proportion of acute heart attacks, particularly STEMI equivalents, leading to delays in life-saving treatment. Queen of Hearts is already addressing this gap in Europe, where following CE-marking it detected over 120,000 heart attacks in 2025, contributing to reduced treatment times in more than half of these cases.

Following the model’s Breakthrough Device Designation in March 2025 and its inclusion in the FDA’s Total Product Life Cycle Advisory Program (TAP), Powerful Medical has received FDA De Novo authorization, establishing a new device classification for AI ECG models targeting acute, life-threatening cardiovascular diagnoses and underscoring recognition of this technology as a meaningful advance over existing diagnostic tools.

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

Queen of Hearts is backed by more than 20 peer-reviewed studies, including randomized controlled trials (RCTs) in high-impact cardiovascular journals spanning over 40,000 patients across four continents. Published data demonstrate approximately twofold higher sensitivity compared to standard of care, alongside up to fivefold fewer false positives and faster time to treatment. Queen of Hearts facilitates the early identification of suspected ACS patients who benefit from early cardiology consultation and early cardiac catheterization.

“Many heart attack patients in the United States still miss the window for life-saving treatment due to delays in diagnosis and inefficient triage,” said Robert Herman, MD, PhD, Chief Medical Officer and Co-founder of Powerful Medical. “With FDA approved technology now available, we can bridge this gap by bringing accurate, real-time ECG interpretation to the first medical contact.” adds Felix Bauer, COO and Co-founder.

With FDA De Novo reclassification of Queen of Hearts, Powerful Medical is accelerating U.S. deployment of PMcardio—a comprehensive AI-driven cardiac care coordination platform built for health systems, integrating ECG interpretation across pre-hospital, emergency departments, and cardiology. The PMcardio platform embeds AI ECG Modules such as Queen of Hearts directly into existing clinical workflows, enabling AI-assisted assessment at first patient contact and seamless handoff to cardiology—reducing time to reperfusion, and improving quality and patient outcomes.

U.S. health systems interested in deploying the FDA-authorized Queen of Hearts model can contact the Powerful Medical team to discuss integration and enterprise rollout.