PMcardio receives FDA Breakthrough Device Designation — read the full story
Get access
Powerful Medical
•
1. October 2024
•
1 min to read
  • Multicenter Clinical Investigation

Time for a Diagnostic Paradigm Shift From STEMI/​NSTEMI to OMI/​NOMI (DIFOCCULT-3)

Link to Publication

Summary

DIFOCCULT-3 is a randomized controlled study actively enrolling patients across 23 sites in Turkey. It evaluates AI-assisted ECG interpretation in detecting high-risk heart attack patterns.

By comparing traditional STEMI/NSTEMI classification with an occlusion/non-occlusion model, the trial aims to improve acute coronary blockage detection. The primary composite endpoint includes all-cause mortality and all-cause re-hospitalization at 1-year follow-up, assessing its impact on long-term patient outcomes.

Study DesignRandomized Controlled Trial (RCT)
StatusEnrolling patients
Countries / Sites1 (Turkey) / 23
Study StartOctober 1, 2024
Primary Completion (estimated)October 1, 2025
Enrollment (target)5,000
clinicaltrials.gov ID NCT06570759

Link to Publication
Author-Logo_PM
Powerful Medical leads one of the most important shifts in modern medicine by augmenting human-made clinical decisions with artificial intelligence. Our primary focus is on cardiovascular diseases, the world’s leading cause of death.

About PMcardio

PMcardio is a CE-certified AI that reads ECGs and offers a complex assessment of 49 cardiac conditions. Clinically validated in 15+ studies and trusted by over 100,000 clinicians, it delivers rapid, expert‑level interpretations, empowering emergency physicians, GPs, nurses, paramedics, and cardiologists to act with confidence at the point of care. Available for Individuals and Organizations.

About Powerful Medical

Established in 2017, Powerful Medical has embarked on a mission to revolutionize the diagnosis and treatment of cardiovascular diseases. We are a medical company backed by 28 world-class cardiologists and led by our expert Scientific Board with decades of experience in daily patient care, clinical research, and medical devices. The results of our research are implemented, developed, certified, and brought to market by our 50+ strong interdisciplinary team of physicians, data scientists, AI experts, software engineers, regulatory specialists, and commercial teams.

Share this article

Relevant Publications

All Publications
  • Abstract
  • Swedish Cardiovascular Spring Meeting, Malmö
  • June 23, 2025

Validation of an artificial intelligence ECG model for detection of acute coronary occlusion myocardial infarction in unselected emergency department chest pain patients

Across 24 513 consecutive chest-pain presentations to five Swedish emergency departments, the Queen of Hearts (QoH) AI-ECG model detected acute coronary occlusion myocardial infarction with 52 % sensitivity and 99 % specificity. It outperformed an extended STEMI algorithm applied to the same cohort (41 % sensitivity, 95 % specificity) and more than doubled the sensitivity of classic STEMI criteria (55 % versus 26 %) while preserving comparable specificity (99 % versus 98 %). This real-world validation demonstrates that QoH markedly improves early ECG recognition of OMI in unselected, non-traumatic chest-pain patients.
  • Abstract
  • German Society of Cardiology (DGK) Congress
  • April 24, 2025

Artificial Intelligence Based Detection of Acute Coronary Occlusion Compared to STEMI Criteria – External Validation Study in a Consecutive All-Comer German Chest Pain Unit Cohort

2nd place - DGK Young Investigator Awards 2025, Germany: In a real-world cohort of over 4,000 chest pain patients presenting to a German CPU, excluding obvious STEMI heart attacks diagnosed before arrival, an AI ECG model detected serious artery blockages (ACO) with 97.8% accuracy. It outperformed traditional STEMI criteria, achieving higher sensitivity (70.2% vs 28.8%) and fewer false positives.
More articles

Join over 100,000 healthcare professionals who are already taking advantage of AI

Download PMcardio app on the Apple App Store
Get PMcardio app on Google Play Store

Ready to get started?

Get access

Powerful Medical is redefining the landscape of medical diagnostics with its AI-driven solutions. The company’s certified PMcardio platform revolutionizes the way cardiovascular diseases are detected, offering rapid and accurate diagnostics that pave the way for timely and effective treatment.

Logo of Next Gen EU
Logo of Next Gen EU

Products

Company

Resources

Legal

Envelope Linkedin-in Instagram Facebook-f

© Powerful Medical 2025

Privacy

&

Cookies

Legal

Powerful Medical, Inc. | PMcardio and the PMcardio logo are registered trademarks of Powerful Medical. Additionally, Queen of Hearts is claimed as a trademark of Powerful Medical.

 

PMcardio is CE-marked as class IIb medical device under EU MDR and only certified for marketing in the European Union and the United Kingdom. PMcardio technology has not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA. Not all modules of the PMcardio platform may be available in your region.

Prior to use, reference the Instructions for Use, for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

PMcardio is CE-marked as class IIb medical device under EU MDR and only certified for marketing in the European Union and the United Kingdom. PMcardio technology has not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA. Not all modules of the PMcardio platform may be available in your region. Prior to use, reference the Instructions for Use, for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

Get access