San Francisco, October 28, 2025 — PMcardio, the leading AI-powered ECG interpretation and care coordination platform, announced today that its Queen of Hearts™ algorithm (STEMI AI ECG Model) achieved breakthrough accuracy in detecting ST-segment elevation myocardial infarction (STEMI) and its equivalents in a large U.S. registry. The findings, presented as Late-Breaking Science at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 conference by Dr. Timothy D. Henry and published simultaneously in JACC: Cardiovascular Interventions, demonstrate that AI-based ECG interpretation significantly improves diagnostic accuracy while substantially reducing false activations.
In one of the largest real-world evaluations of AI-assisted STEMI triage to date, investigators analyzed 1,032 patients who triggered emergent reperfusion protocols across three geographically distinct U.S. PCI centers—reflecting diverse clinical settings, patient demographics, and operational workflows. The Queen of Hearts™ model correctly identified 92% of true STEMIs on the initial ECG compared with 71% under standard triage, while reducing false-positive activations from 42% to 8%—a fivefold improvement.
“These results demonstrate that AI-enhanced ECG interpretation at first medical contact can both expedite diagnosis and minimize false activations,” said Dr. Timothy D. Henry, Director of Clinical Research at The Christ Hospital, Cincinnati and past president of Society for Cardiovascular Angiography and Interventions (SCAI), “this approach may be particularly valuable for optimizing transfers from non-PCI centers, where only 17% of patients currently achieve timely reperfusion.”
The results build on the promising secondary endpoint data from the DIFOCCULT-3 Randomized Controlled Trial (RCT)—the largest randomized study of AI in cardiology to date, enrolling 6,000 patients with acute coronary syndromes across 18 PCI centers in Turkey—which observed shorter reperfusion times (up to five hours faster) and improved short-term outcomes in the AI-assisted arm. These secondary endpoint data were also presented at the TCT 2025 conference in San Francisco as part of the Best Global Research session. Data on the impact on long-term survival are expected next year.
“These consistent results from both real-world and randomized studies highlight the potential of AI to bridge the diagnostic gap in STEMI management,” said Dr. Robert Herman, PhD, Chief Medical Officer and Co-Founder at Powerful Medical, “with up to 40% of STEMI cases presenting with atypical ECGs, our technology helps ensure these patients are recognized early and reach lifesaving care in time.”
The Queen of Hearts™ algorithm, trained on millions of ECGs, also provides visual explanations that show clinicians which parts of the ECG most influence its decisions—helping them better understand and trust the AI’s findings. Together, these studies underscore the technology’s potential to transform emergency cardiac care by improving diagnostic accuracy, driving care coordination, reducing unnecessary procedures, and saving more lives worldwide.
Ref:
- Queen of Hearts U.S. STEMI Validation Study — JACC: Cardiovascular Interventions: https://doi.org/10.1016/j.jcin.2025.10.018
- DIFOCCULT-3 Randomized Controlled Trial Design — JACC: Advances: https://www.jacc.org/doi/10.1016/j.jacadv.2025.102227
About PMcardio and Powerful Medical
PMcardio is a diagnostic and care coordination platform developed by Powerful Medical, a medical device manufacturer specializing in AI-driven cardiovascular diagnostics. Clinically validated to detect 49 cardiac conditions from an ECG, it identifies acute heart attacks up to three hours earlier and with twice the sensitivity of the current standard of care. This enables timely and accurate triage in emergency settings. By reducing treatment delays and door-to-balloon times, PMcardio facilitates optimized care for chest pain patients. Already class IIb CE-marked under EU MDR in Europe, and pending FDA approval, it enhances acute cardiac care by supporting faster, more confident clinical decisions.
For more information about PMcardio and its breakthrough technology, visit www.powerfulmedical.com.
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