The U.S. Food and Drug Administration has granted De Novo authorization to Queen of Hearts, an artificial intelligence model built to read electrocardiograms and catch acute heart attacks that standard tests often miss. The clearance, announced by developer Powerful Medical, makes it the world's first FDA-authorized AI ECG solution designed specifically to detect acute coronary syndrome, a category that includes ST-elevation myocardial infarction and its trickier equivalents.
The authorization matters because electrocardiograms are used in evaluating heart attacks, yet standard ST-elevation criteria fail to identify up to half of acute coronary occlusions requiring urgent catheterization, according to Powerful Medical. Queen of Hearts was built around the Occlusion Myocardial Infarction paradigm pioneered by emergency physicians Dr. Stephen W. Smith and Dr. H. Pendell Meyers, a framework designed to catch subtle warning signs like hyperacute T-waves and de Winter patterns that classic STEMI criteria can overlook. As reported by the Eagle-Tribune, the tool is designed to identify ECG findings suggestive of urgent acute coronary syndrome and urgently notify clinicians so they can move quickly toward catheterization or cardiology consultation.
The Numbers Behind the Clearance
The clinical case for the technology rests on a 1,032-patient multicenter U.S. registry study presented at TCT 2025 and published in JACC: Cardiovascular Interventions. That study found Queen of Hearts reduced false-positive catheterization lab activations from 41.8% under standard care down to 7.9%, while achieving 92% sensitivity compared with 71% for standard triage, per findings covered by TCTMD. False catheterization lab activations are among the outcomes measured in assessing triage performance.
A separate study in the American Journal of Emergency Medicine tested the model against 53 emergency physicians and 42 cardiologists on complex ECG patterns. Human doctors correctly identified STEMI-equivalent and STEMI-mimic patterns 65.6% of the time, while Queen of Hearts hit 88.9% accuracy on the same cases. The Eagle-Tribune reported the model has been evaluated in more than 20 studies involving more than 40,000 patients and has demonstrated up to fivefold fewer false positives and roughly twofold higher sensitivity compared with standard care.
A Regulatory Path Years in the Making
Powerful Medical's route to clearance began well before this month's decision. The company received FDA Breakthrough Device Designation for its PMcardio STEMI AI ECG model in March 2025, a status reserved for technologies targeting life-threatening or irreversibly debilitating conditions, according to Medical Device Network. The FDA's De Novo pathway was used for the authorization, per the U.S. Food and Drug Administration.
The technology already has a track record overseas. Following European CE mark authorization under the EU Medical Device Regulation in May 2022, Queen of Hearts analyzed ECGs that led to the detection of more than 120,000 heart attacks across Europe in 2025, reducing treatment times in more than half of those cases, according to Guided Solutions. The platform has been used in ambulance and emergency-care settings in Europe before the U.S. clearance arrived.
Why Rural Hospitals Are Watching Closely
The stakes are especially high for hospitals without round-the-clock cardiology coverage. A cited statistic puts the share of STEMI patients reaching life-saving intervention in time at 17%. That gap helps explain why an automated triage tool that flags urgent cases and requires cardiologist activation could reshape care in community hospitals that lack on-site interventional specialists.
The scale of the underlying heart-disease problem is enormous. Heart disease remains a major health concern. Against that backdrop, the Eagle-Tribune reported Queen of Hearts is now designed to integrate AI ECG interpretation across pre-hospital, emergency department and cardiology settings nationwide.
Company Background and What Comes Next
Powerful Medical was founded in 2017 and operates in the United States and Slovakia. The company has also pursued work in health technology. Its broader PMcardio platform, which includes Queen of Hearts alongside other ECG models, is already used by more than 100,000 clinicians across hospitals, emergency medical services and cardiac centers worldwide, per the Eagle-Tribune's report.
Validation work continues even after clearance. In December 2024, Powerful Medical launched a multi-center observational AI-ECG TIMI validation study with international cardiovascular researchers to evaluate the platform's diagnostic performance across diverse real-world health systems. With De Novo authorization now in hand, the technology is expected to see uptake in U.S. health systems, positioning Queen of Hearts as a new category of tool for emergency rooms and cardiology units grappling with a steady stream of ambiguous, high-stakes cases.
