Powerful Medical gets FDA De Novo authorization for Queen of Hearts AI heart attack ECG model

What Powerful Medical announced

Powerful Medical, the company behind the PMcardio ECG platform, announced on 15 September 2026 that the US Food and Drug Administration granted De Novo authorization for Queen of Hearts, listed as the ACS AI ECG Model. The model looks for ECG findings that suggest urgent acute coronary syndrome, including ST-segment elevation myocardial infarction (STEMI) and so-called STEMI equivalents, and sends an urgent notification to clinicians when it finds a suspected case.

The FDA database lists the request as DEN250044, received on 22 September 2025 with a decision dated 3 September 2026. De Novo is the route for new devices with no existing equivalent on the US market. Powerful Medical says the decision establishes a new device classification for AI ECG models that target acute, life-threatening heart conditions. The model received Breakthrough Device Designation in March 2025 and was part of the FDA's Total Product Life Cycle Advisory Program.

The numbers behind the model

Powerful Medical says Queen of Hearts is supported by more than 20 peer-reviewed studies, including randomized controlled trials, covering over 40,000 patients on four continents. The company reports roughly twice the sensitivity of standard-of-care ECG reading, up to five times fewer false positives, and faster time to treatment. After CE marking in Europe, the company says the model detected over 120,000 heart attacks in 2025 and helped reduce treatment times in more than half of those cases.

PMcardio reads any 12-lead ECG from a photo or a digital file in seconds and detects more than 50 ECG findings. Powerful Medical says more than 100,000 clinicians use it, they have analyzed over 2.5 million ECGs, and the platform runs in more than 150 hospital deployments worldwide. Chief executive Martin Herman says the authorization lets the company bring the technology into routine clinical care across the United States.

Why it matters

Standard ECG criteria are built around ST elevation, and Powerful Medical argues that many blocked arteries do not show that pattern on the first ECG. An AI reader that catches those cases at first medical contact could shorten the path to catheterization. The accuracy figures are the company's own summary of published studies; US hospitals will want results from their own patients. The first commercial hurdle followed quickly. On 27 October 2026 the company said the AMA had created Category III CPT code 1139T for this kind of AI ECG analysis, effective 1 January 2027.

The authorization is one of several cardiac AI decisions this autumn. Elucid announced FDA clearance of FFR-IQ, a CT-based blood flow tool, in October. More sector stories are under AI in Industry.

What to watch next

Watch for the first named US health systems to deploy the model, the pricing model for hospitals, and whether payers cover the new CPT code after it takes effect in January 2027.

Questions people ask

What does Queen of Hearts detect?

It flags ECG findings suggestive of urgent acute coronary syndrome, including STEMI and STEMI equivalents, and notifies clinicians of suspected cases, according to Powerful Medical.

What is an FDA De Novo authorization?

It is the FDA route for a new low or moderate risk device that has no legally marketed equivalent. The decision creates a new device classification that later products can reference.

Is there a billing code for Queen of Hearts?

Powerful Medical said on 27 October 2026 that the AMA created Category III CPT code 1139T for this service, effective 1 January 2027.

Sources

1. Powerful Medical Receives FDA De Novo Approval for PMcardio Queen of Hearts, Its AI ECG Model for Detecting Acute Heart Attacks (Powerful Medical, 15 Sep 2026)
2. De Novo record DEN250044: Queen of Hearts (ACS AI ECG Model) (U.S. Food and Drug Administration (openFDA), 3 Sep 2026)
3. Powerful Medical Granted CPT Code for AI ECG Heart Attack Detection, Weeks After FDA De Novo Authorization of Queen of Hearts (Powerful Medical, 27 Oct 2026)