FDA Clears First AI-ECG Tool for Acute Heart Attack Detection

The FDA has granted De Novo authorization to Queen of Hearts, an artificial intelligence-powered electrocardiogram analysis tool designed to detect STEMI and STEMI equivalents in patients with suspected acute coronary syndromes, manufacturer Powerful Medical announced.

This marks the first FDA authorization specifically for an AI-ECG model targeting acute coronary syndrome that requires urgent cardiologist review and intervention, according to Robert Herman, MD, PhD, chief medical officer and co-founder of Powerful Medical. The authorization establishes a new device classification for AI-ECG models addressing acute, life-threatening cardiovascular diagnoses.

The Queen of Hearts model, deployed through Powerful Medical's PMcardio platform for cardiac care coordination, goes beyond simple detection. "Our intended use goes beyond detection alone and includes triage/prioritization and notification of the appropriate clinician or cardiology team," Herman said.

Clinical evidence and performance

More than 20 peer-reviewed studies involving over 40,000 patients support the platform's use. Research has demonstrated improved sensitivity compared with standard decision-making, reductions in false-positive catheterization lab activations, and shorter treatment times.

At TCT 2025, Timothy Henry, MD, of The Christ Hospital in Cincinnati presented retrospective registry data showing the AI model outperformed standard decision-making for STEMI detection across three primary PCI networks in the United States. The false-positive activation rate was 7.9% when using the AI tool versus 41.8% without it. Those findings were published simultaneously in JACC: Cardiovascular Interventions.

Henry told TCTMD the technology leads to faster recognition of STEMI and STEMI equivalents—including hyperacute T waves and posterior MI—while decreasing false positives. "I think this is going to become pretty much standard of care," he said.

Deployment readiness

The AI-ECG model will prove particularly valuable at non-PCI centers, Henry predicted, because "it allows everybody to have expertise." The platform includes a feature that explains why a specific ECG is flagged as positive for STEMI or a STEMI equivalent, which can help educate physicians and improve ECG recognition skills.

Multiple U.S. health systems have already integrated the technology and are awaiting FDA authorization to activate it, Herman said. The company is working with Henry and other clinicians to facilitate rapid adoption across the country.

Queen of Hearts received the FDA's breakthrough device designation in March 2025 and was included in the agency's Total Product Life Cycle Advisory Program, which accelerates development of innovative medical devices. The platform obtained CE Mark approval in Europe in 2022.

Why it matters

Rapid, accurate identification of acute myocardial infarction directly impacts patient survival and outcomes. By reducing false-positive cath lab activations by more than 80% while improving detection sensitivity, this AI tool addresses two critical pain points in emergency cardiac care: missed diagnoses and resource waste. For health systems, the technology promises to extend specialist-level ECG interpretation to facilities without on-site cardiology expertise, potentially narrowing care quality gaps between academic centers and community hospitals.

These details were first reported by TCTMD.