The US Food and Drug Administration (FDA) has granted de novo authorisation to Powerful Medical’s Queen of Hearts, an AI model for acute coronary syndrome (ACS) detection via electrocardiogram (ECG) analysis.
Queen of Hearts is designed for the early identification of suspected ACS patients who may benefit from early cardiology consultation and early cardiac catheterisation. ACS is primarily shorthand for heart attack, but the umbrella term also encompasses conditions like unstable angina that often serve as critical warning signs that a heart attack may happen soon.
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While ECG is the primary diagnostic tool, standard of care (SoC) interpretation often fails to detect a significant proportion of acute heart attacks, particularly STEMI equivalents, leading to delays in life-saving treatment, Powerful stated.
STEMI equivalents refer to specific ECG patterns that indicate acute coronary occlusion or severe ischemia requiring emergency cardiac catheterisation, even though they do not meet traditional ST-elevation criteria. ST-elevation, meanwhile, refers to a specific upward curve or rise seen on an ECG that frequently means a patient is experiencing STEMI myocardial infarction, a serious type of heart attack caused by a complete and sudden blockage of a coronary artery.
The company, which has locations in both the US and Slovakia, asserts that Queen of Hearts is already ideating on the SoC gap for acute heart attacks in Europe since obtaining CE mark in 2022. The model detected over 120,000 heart attacks in 2025, contributing to reduced treatment times in more than half of these cases.
Queen of Hearts’ efficacy is backed by over 20 peer-reviewed studies, including randomised controlled trials (RCTs) that have included over 40,000 patients. The published data demonstrate approximately twofold higher sensitivity compared to SoC, alongside up to fivefold fewer false positives and faster time to treatment, the company stated.
With de novo classification in hand, Powerful intends to accelerate the deployment of PMcardio, the platform on which Queen of Hearts runs, across healthcare settings in the US. PMcardio secured breakthrough device designation from the FDA in March 2025.
Powerful’s CMO, Robert Herman, highlighted many heart attack patients in the US still “miss the window” for life-saving treatment due to delays in diagnosis and inefficient triage.
Powerful’s co-founder and chief operating officer, Felix Bauer, continued: “With FDA approved technology now available, we can bridge this gap by bringing accurate, real-time ECG interpretation to the first medical contact.”
