Queen of Hearts AI ECG: FDA De Novo for Heart Attack Detection

The FDA has authorized Powerful Medical’s Queen of Hearts, an AI model that reads a standard 12 lead ECG for signs of an acute heart attack, including the subtle patterns that classic STEMI criteria miss.

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Quick answer, verified October 20, 2026

Queen of Hearts is an AI ECG model from Powerful Medical that flags ECGs suggestive of an urgent acute coronary syndrome, the kind of blocked artery heart attack that needs a catheterization lab. The FDA granted it De Novo authorization in September 2026 (DEN250044), making it the first FDA authorized AI ECG tool built specifically for this job, according to the company.

Who uses it: clinicians in ambulances, emergency departments and cardiology, not consumers.
Key result: in a US registry study published in JACC: Cardiovascular Interventions, false positive cath lab activations fell from 41.8% to 7.9%, while sensitivity rose to 92% from 71% with standard triage.
Evidence base: evaluated in more than 20 studies involving more than 40,000 patients, per company reporting.
Europe: CE marked since May 2022.
Safeguard: it notifies clinicians; a cardiologist still decides whether to activate the cath lab.

The short verdict

Heart attack triage has a well known blind spot. The traditional rule for sending a patient straight to the catheterization lab depends on ST segment elevation on the ECG, but some patients with a completely blocked coronary artery never show textbook elevation, while others show elevation for reasons that are not a heart attack. The result is two kinds of error: missed occlusions and unnecessary emergency activations. Queen of Hearts is designed to narrow both, and the published registry data suggest it does.

For patients, the practical meaning is faster, more accurate decisions in the first minutes of care, especially in hospitals without a cardiologist on site around the clock.

What Queen of Hearts does

The model analyzes a standard 12 lead ECG and identifies findings suggestive of an urgent acute coronary syndrome, a category that includes ST elevation myocardial infarction (STEMI) and its harder to spot equivalents. It was built around the occlusion myocardial infarction framework developed by emergency physicians Dr. Stephen Smith and Dr. H. Pendell Meyers, which teaches clinicians to look for signs such as hyperacute T waves and de Winter patterns that classic STEMI criteria can overlook.

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When the model detects a concerning pattern, it urgently notifies clinicians so they can move faster. Cath lab activation still requires a cardiologist’s decision.

The evidence behind the authorization

Registry study: a multicenter US registry presented at TCT 2025 and published in JACC: Cardiovascular Interventions found false positive cath lab activations dropped from 41.8% under standard care to 7.9% with Queen of Hearts, and sensitivity reached 92% compared with 71% for standard triage.
Head to head with physicians: in a study in the American Journal of Emergency Medicine, 53 emergency physicians and 42 cardiologists correctly identified complex STEMI equivalent and STEMI mimic patterns 65.6% of the time, while Queen of Hearts reached 88.9% on the same cases.
Scale: the model has been evaluated in more than 20 studies involving more than 40,000 patients, with up to five fold fewer false positives and roughly twice the sensitivity of standard care, according to reporting cited at authorization.

Regulatory path

Powerful Medical received FDA Breakthrough Device Designation for its PMcardio STEMI AI ECG model in March 2025, a status reserved for technologies that target life threatening conditions. The De Novo authorization in September 2026 creates a new device category in the US. In Europe, Queen of Hearts has held a CE mark under the EU Medical Device Regulation since May 2022, and the company reports it analyzed ECGs that led to the detection of more than 120,000 heart attacks across Europe in 2025.

Why rural and community hospitals care

Hospitals without round the clock interventional cardiology depend on fast, accurate transfer decisions. A tool that flags true occlusions earlier and cuts false alarms can shorten time to treatment for real heart attacks while avoiding costly, risky transfers for patients who do not need them. Powerful Medical says its broader PMcardio platform is already used by more than 100,000 clinicians worldwide across hospitals, emergency medical services and cardiac centers.

What this means for patients and smartwatch ECGs

Queen of Hearts reads a full 12 lead ECG recorded by medical staff. It is not a smartwatch feature. Consumer ECG apps on devices such as the Garmin Venu 3 and Fitbit Charge 6 record a single lead to screen for atrial fibrillation and cannot rule out a heart attack. If you have chest pain, pressure, shortness of breath or other heart attack symptoms, call emergency services rather than checking a watch. For more on how AI is entering cardiac care, see our overview of FDA authorized AI in cardiology.

Limitations and open questions

Real world rollout: results in US hospitals at scale will depend on how the alerts are integrated into clinical workflows.
Study design: registry studies are observational. Ongoing validation work, including a multicenter study Powerful Medical launched in December 2024, will add evidence across diverse health systems.
Human oversight: the tool supports but does not replace clinical judgment and cardiologist review.

Frequently asked questions

What is the Queen of Hearts AI ECG?

It is an AI model from Powerful Medical that analyzes 12 lead ECGs to detect findings suggestive of urgent acute coronary syndrome, including STEMI and STEMI equivalents, and alerts clinicians.

Is Queen of Hearts FDA approved?

It received FDA De Novo authorization in September 2026, after Breakthrough Device Designation in March 2025.

How accurate is Queen of Hearts?

In a US registry study, it reduced false positive cath lab activations from 41.8% to 7.9% and reached 92% sensitivity versus 71% for standard triage.

Can I use Queen of Hearts on my smartwatch?

No. It is a clinical tool that reads 12 lead ECGs recorded by medical teams. Smartwatch ECGs are single lead and cannot rule out a heart attack.

Sources

This article is for general information and is not medical advice. If you think you are having a heart attack, call emergency services immediately.

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