Powerful Medical Receives FDA De Novo Approval for PMcardio Queen of Hearts AI ECG Platform
核心洞察
The FDA has granted De Novo authorization to Powerful Medical (搜索)'s Queen of Hearts (搜索) AI ECG model for detecting ECG findings suggestive of urgent acute coronary syndrome (搜索).
The authorization establishes a new device classification for AI ECG models targeting acute, life-threatening cardiovascular diagnoses, following Breakthrough Device Designation in March 2025.
Queen of Hearts (搜索) is backed by more than 20 peer-reviewed studies covering over 40,000 patients, with data showing roughly twofold higher sensitivity than standard of care.
Powerful Medical (搜索) has received FDA De Novo authorization for Queen of Hearts (搜索), an AI ECG model designed to identify ECG findings suggestive of urgent acute coronary syndrome (搜索) (ACS), which can include ST-segment elevation myocardial infarction (搜索) (STEMI) and STEMI equivalents, and to urgently notify clinicians of suspected cases. The company said the decision establishes a new device classification for AI ECG models targeting acute, life-threatening cardiovascular diagnoses. It follows Breakthrough Device Designation in March 2025 and inclusion in the FDA's Total Product Life Cycle Advisory Program (TAP).
The model is backed by more than 20 peer-reviewed studies, including randomized controlled trials spanning over 40,000 patients across four continents. Published data demonstrate approximately twofold higher sensitivity compared with standard of care, up to fivefold fewer false positives and faster time to treatment. Queen of Hearts (搜索) is already in use in Europe, where following CE-marking it detected over 120,000 heart attacks in 2025 and contributed to reduced treatment times in more than half of those cases.
With the De Novo reclassification, Powerful Medical (搜索) is accelerating U.S. deployment of PMcardio (搜索), its cardiac care coordination platform for health systems that integrates ECG interpretation across pre-hospital settings, emergency departments and cardiology. The platform embeds AI ECG modules such as Queen of Hearts (搜索) into existing clinical workflows to support AI-assisted assessment at first patient contact and handoff to cardiology. PMcardio is used by more than 100,000 clinicians across hospitals, EMS and cardiac centers worldwide.