FDA Grants De Novo to Powerful Medical's Queen of Hearts AI Model for Heart Attack ECGs

The FDA has granted a De Novo request for Queen of Hearts, an artificial intelligence model from Powerful Medical that analyzes electrocardiograms (ECGs) to flag suspected acute coronary syndrome, according to the agency's De Novo database. The entry, DEN250044, lists the device as "Queen of Hearts (ACS AI ECG Model)" with a decision date of September 3, 2026.

A De Novo grant creates a new device classification for a low-to-moderate-risk product that has no predicate on the market. The record shows the request was received on September 22, 2025, was reviewed by the cardiovascular advisory panel area, and was assigned the product code SHS. It also shows that a predetermined change control plan was authorized, a mechanism that lets a manufacturer make specified changes to a device after authorization under a plan the FDA has reviewed in advance.

What the software is for

Queen of Hearts is designed for the early identification of suspected acute coronary syndrome patients who may benefit from early cardiology consultation and cardiac catheterisation, Medical Device Network reported on September 7. Acute coronary syndrome is largely shorthand for heart attack but also covers conditions such as unstable angina.

The company's case for the product rests on the limits of standard ECG reading. According to Medical Device Network, Powerful Medical said standard-of-care interpretation often misses a significant share of acute heart attacks, in particular STEMI equivalents. Those are ECG patterns that point to an acute blockage of a coronary artery or severe ischemia needing emergency catheterisation even though they do not meet the traditional ST-elevation criteria that clinicians use to identify the most serious type of heart attack.

Powerful Medical, which has offices in New York and Slovakia, said the model has been in use in Europe since it received a CE mark in 2022 and detected more than 120,000 heart attacks in 2025, contributing to reduced treatment times in more than half of those cases, Medical Device Network reported. The company also cited more than 20 peer-reviewed studies, including randomised controlled trials, covering more than 40,000 patients. It said published data show roughly twice the sensitivity of standard care with up to five times fewer false positives. Those performance figures are the company's own summary and are not part of the FDA's database entry.

Regulatory path and next steps

The FDA gave breakthrough device designation to PMcardio, the platform on which Queen of Hearts runs, in March 2025, according to Medical Device Network. The De Novo entry lists the decision type as direct, meaning the company asked for De Novo classification without first filing a 510(k).

With the classification in place, Powerful Medical intends to speed up deployment of PMcardio across US healthcare settings, Medical Device Network reported. Robert Herman, the company's chief medical officer, said many US heart attack patients still "miss the window" for treatment because of delays in diagnosis and inefficient triage, according to the report.

The database entry names Powerful Medical, Inc. of New York as the requester. Neither the FDA record nor the company's statements as reported gave pricing or a US launch date.