Powerful Medical has received FDA De Novo authorisation for Queen of Hearts, an AI-powered ECG model designed to identify findings associated with acute coronary syndrome (ACS), including ST-segment elevation myocardial infarction (STEMI) and STEMI equivalents.
The technology analyses ECG data to identify suspected urgent cardiac events and alert clinicians, supporting earlier assessment and treatment.
The FDA authorisation also establishes a new device classification for AI-based ECG models intended to address acute cardiovascular conditions.
Queen of Hearts previously received FDA Breakthrough Device Designation in March 2025 and was included in the FDA’s Total Product Life Cycle Advisory Program.
The model is supported by more than 20 peer-reviewed studies involving over 40,000 patients across four continents.
According to data cited by Powerful Medical, the technology has demonstrated approximately twice the sensitivity of standard ECG interpretation, while reducing false-positive results and supporting faster treatment.
Following CE marking, the model was also deployed in Europe, where the company reported that it detected more than 120,000 heart attacks in 2025.
Powerful Medical plans to expand US deployment through its PMcardio platform, which integrates AI-assisted ECG analysis into pre-hospital, emergency department and cardiology workflows.
The company said the platform is designed to support earlier identification of suspected ACS cases and improve coordination between clinical teams.
