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FDA Grants De Novo Clearance to Powerful Medicals Queen of Hearts AI-ECG Model for STEMI Detection
On September 6, 2026 the U.S. Food and Drug Administration issued a De Novo authorization for Powerful Medical’s Queen of Hearts artificial‑intelligence (AI) electrocardiogram (ECG) model. The clearance authorizes the tool to identify ST‑elevation myocardial infarction (STEMI) and STEMI‑equivalent patterns in patients with suspected acute coronary syndrome (ACS) who require urgent cardiologist review.
Queen of Hearts is the first FDA‑approved AI‑ECG that targets ACS with an indication for immediate clinical action. The company deploys the model through its PMcardio platform, which coordinates cardiac care by triaging patients, prioritizing cases, and notifying the appropriate cardiology team.
Performance data come from more than 20 peer‑reviewed studies involving over 40,000 patients. Across these studies the model has demonstrated higher sensitivity than standard decision rules, fewer false‑positive catheterization laboratory activations, and shorter times to treatment. At the 2025 TCT conference Dr. Timothy Henry of The Christ Hospital presented a retrospective registry study comparing the AI tool to conventional criteria across three primary percutaneous coronary intervention (PCI) networks. Published in JACC: Cardiovascular Interventions, the study reported false‑positive rates of 7.9 % with the AI model versus 41.8 % without it.
In a statement to TCTMD, Dr. Henry said the AI‑ECG improves recognition of STEMI and STEMI‑equivalent presentations such as hyperacute T‑waves and posterior infarcts. He added that the tool should shorten treatment times and reduce unnecessary activations, and that it will become a standard of care in the United States.
Queen of Hearts earned FDA breakthrough device designation in March 2025 and was included in the agency’s Total Product Life Cycle (TPLC) Advisory Program, which accelerates development of innovative medical devices. The model previously obtained CE Mark approval in Europe in 2022.
Powerful Medical noted that it already has contracts with multiple U.S. health systems that are integrated and ready to deploy the technology. The company is working closely with Dr. Henry and other stakeholders to facilitate rapid uptake.
The De Novo clearance establishes a new device classification for AI‑ECG models that target acute, life‑threatening cardiovascular diagnoses, underscoring the FDA’s recognition of AI‑enabled diagnostics as a meaningful advance over existing tools.
Hospitals are actively seeking ways to improve early detection of heart attacks and reduce the burden on catheterization laboratories. By providing real‑time alerts and explainable results, Queen of Hearts could help non‑PCI centers triage patients more effectively and educate clinicians on subtle ECG findings.
The FDA’s decision is expected to influence adoption patterns across the U.S. healthcare system. While the model’s performance has been validated in large registries, Powerful Medical and its partners will need to monitor real‑world outcomes and continue refining the algorithm as new data become available.
In summary, the FDA’s De Novo authorization marks a milestone for AI‑based cardiac diagnostics. Queen of Hearts is positioned to enhance STEMI detection, reduce false positives, and streamline care pathways. The next steps involve scaling deployment, integrating the tool into existing electronic health record workflows, and gathering post‑market evidence to confirm its impact on patient outcomes.
Queen of Hearts is the first FDA‑approved AI‑ECG that targets ACS with an indication for immediate clinical action. The company deploys the model through its PMcardio platform, which coordinates cardiac care by triaging patients, prioritizing cases, and notifying the appropriate cardiology team.
Performance data come from more than 20 peer‑reviewed studies involving over 40,000 patients. Across these studies the model has demonstrated higher sensitivity than standard decision rules, fewer false‑positive catheterization laboratory activations, and shorter times to treatment. At the 2025 TCT conference Dr. Timothy Henry of The Christ Hospital presented a retrospective registry study comparing the AI tool to conventional criteria across three primary percutaneous coronary intervention (PCI) networks. Published in JACC: Cardiovascular Interventions, the study reported false‑positive rates of 7.9 % with the AI model versus 41.8 % without it.
In a statement to TCTMD, Dr. Henry said the AI‑ECG improves recognition of STEMI and STEMI‑equivalent presentations such as hyperacute T‑waves and posterior infarcts. He added that the tool should shorten treatment times and reduce unnecessary activations, and that it will become a standard of care in the United States.
Queen of Hearts earned FDA breakthrough device designation in March 2025 and was included in the agency’s Total Product Life Cycle (TPLC) Advisory Program, which accelerates development of innovative medical devices. The model previously obtained CE Mark approval in Europe in 2022.
Powerful Medical noted that it already has contracts with multiple U.S. health systems that are integrated and ready to deploy the technology. The company is working closely with Dr. Henry and other stakeholders to facilitate rapid uptake.
The De Novo clearance establishes a new device classification for AI‑ECG models that target acute, life‑threatening cardiovascular diagnoses, underscoring the FDA’s recognition of AI‑enabled diagnostics as a meaningful advance over existing tools.
Hospitals are actively seeking ways to improve early detection of heart attacks and reduce the burden on catheterization laboratories. By providing real‑time alerts and explainable results, Queen of Hearts could help non‑PCI centers triage patients more effectively and educate clinicians on subtle ECG findings.
The FDA’s decision is expected to influence adoption patterns across the U.S. healthcare system. While the model’s performance has been validated in large registries, Powerful Medical and its partners will need to monitor real‑world outcomes and continue refining the algorithm as new data become available.
In summary, the FDA’s De Novo authorization marks a milestone for AI‑based cardiac diagnostics. Queen of Hearts is positioned to enhance STEMI detection, reduce false positives, and streamline care pathways. The next steps involve scaling deployment, integrating the tool into existing electronic health record workflows, and gathering post‑market evidence to confirm its impact on patient outcomes.
