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The FDA has granted de novo authorization to Powerful Medical's Queen of Hearts, an AI model that analyzes electrocardiogram (ECG) readings to detect acute coronary syndrome (ACS), including heart attacks and STEMI-equivalent patterns that traditional ST-elevation criteria can miss. The clearance follows breakthrough device designation granted to the company's broader PMcardio platform in March 2025.
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Queen of Hearts is designed to flag suspected ACS patients earlier, prompting timely cardiology consultation and cardiac catheterization. Standard ECG interpretation often misses a meaningful share of acute heart attacks, particularly STEMI-equivalent patterns that indicate severe blockage or ischemia without meeting classic ST-elevation criteria, according to Powerful Medical. The company, which operates in both the US and Slovakia, has held CE mark authorization for the model in Europe since 2022 and reports the model detected more than 120,000 heart attacks in 2025, contributing to reduced treatment times in over half of those cases.
The model's performance is supported by more than 20 peer-reviewed studies, including randomized controlled trials covering over 40,000 patients, which the company says show roughly double the sensitivity of standard-of-care interpretation and up to five times fewer false positives.
For Powerful Medical, the clearance opens the door to accelerated US deployment of PMcardio. For the broader MedTech space, it adds to growing momentum for AI-based ECG interpretation tools aimed at reducing time-to-treatment in acute cardiac care, an area where diagnostic delay remains a persistent driver of poor outcomes.
CMO Robert Herman said many US heart attack patients still "miss the window" for timely treatment due to diagnostic delays.
