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Powerful Medical
28. October 2025

PMcardio Reports Positive RCT Results and Late-Breaking Clinical Science for STEMI Detection

Queen of Hearts AI ECG Analysis Demonstrates Breakthrough Accuracy in STEMI Diagnosis

Presented as Late-Breaking Science at TCT 2025 by Dr. Timothy D. Henry, simultaneously published in JACC: Cardiovascular Interventions

San Francisco, October 28, 2025 — A new study presented today at the Transcatheter Cardiovascular Therapeutics (TCT) conference demonstrated that using artificial intelligence (AI) to analyze electrocardiograms (ECGs) significantly improves detection of severe heart attacks (STEMI and STEMI equivalents) while reducing false-positive cath lab activations.

The study, published simultaneously in JACC: Cardiovascular Interventions, highlights how AI-based ECG interpretation could transform emergency cardiac care by enabling faster and more accurate triage from the moment of first medical contact.

Key Findings

In one of the first large, real-world evaluations of an AI-based ECG model for STEMI triage, researchers analyzed 1,032 patients who triggered emergency reperfusion protocols across three geographically diverse primary PCI centers between 2020 and 2024. Angiography and biomarker results confirmed that 58% of patients had true STEMIs, while 42% represented false-positive activations.

The STEMI AI ECG modelQueen of Hearts™—correctly identified 92% of true STEMIs on the initial ECG, compared with 71% detected by standard triage methods.

Moreover, Queen of Hearts also reduced false activations dramatically, achieving a false-positive rate of 7.9% versus 41.8% with standard triage—representing a fivefold reduction in unnecessary activations.

Learn more about the clinical validation of the Queen of Hearts™ AI model in the full publication:
Read the study in JACC: Cardiovascular Interventions

“These results indicate that AI-enhanced STEMI diagnosis at the first medical contact has the potential to shorten time to treatment and reduce false activations,” commented Dr. Timothy D. Henry, Director of Clinical Research at The Christ Hospital in Cincinnati and past president of the Society for Cardiovascular Angiography and Interventions (SCAI). “This technology may be especially valuable in optimizing the transfer of STEMI patients from non-PCI centers to ensure timely and appropriate care, currently only 17% of these patients make it to life-saving intervention in time”.

The Study in Context

ST-segment elevation myocardial infarction (STEMI) is a severe type of heart attack caused by the complete blockage of a major coronary artery. Rapid reperfusion through percutaneous coronary intervention (PCI) is lifesaving, yet many patients still face delays—especially in rural or non-PCI hospitals—where time-to-reperfusion exceeding 90 minutes triples mortality risk.

Traditional ECG interpretation can miss “STEMI equivalents,” subtle or atypical ECG presentations that represent acute coronary occlusion and should be emergently managed based on international guidelines. The Queen of Hearts™ model was designed to close this gap, trained on millions of ECGs to identify both typical and atypical occlusions, and to distinguish them from benign patterns like early repolarization or left ventricular hypertrophy.

“Up to 40% of STEMI patients do not present with typical ECG findings” said Dr. Robert Herman, PhD, lead author Chief Medical Officer at Powerful Medical and cardiovascular researcher at AZORG Hospital, Aalst, Belgium. “AI-driven ECG interpretation can reduce diagnostic gaps, especially at the first medical contact, streamlining access to care”.

Why It Matters

Each year, millions of ECGs are performed worldwide, yet diagnostic variability remains high, particularly for borderline or non-classic presentations of acute coronary occlusion. False-positive activations can strain hospital resources and increase costs, while missed occlusions delay critical treatment.

AI-driven tools like PMcardio’s Queen of Hearts™ offer a scalable, explainable, and validated approach to improving both accuracy and efficiency in emergency cardiac care. Beyond its proven accuracy in this study, the model also includes explainability heatmaps (ECGxplain™) that show which ECG regions contributed most to its decision—helping clinicians trust and understand AI-assisted results.


DIFOCCULT-3 RCT Confirms Clinical Impact of AI-Guided Occlusion Myocardial Infarction (OMI) Diagnosis

Results from the DIFOCCULT-3 Randomized Controlled Trial, the largest AI study in cardiology and emergency medicine, further reinforce PMcardio’s clinical value in reducing time to treatment in subtle coronary occlusions. Conducted across 18 primary PCI centers and enrolling 6,000 patients with acute coronary syndromes (ACS), the RCT compared the traditional Standard of Care ECG interpretation with an AI-assisted Occlusive/Non-Occlusive MI (OMI/NOMI) framework.

The AI-assisted arm achieved significantly faster reperfusion times and better post-PCI outcomes, including:

  • nearly 5-hour reduction in ECG-to-balloon time for acute coronary occlusion patients without typical ST-elevation (p < 0.001)
  • shorter door-to-balloon times (<90 min) (p < 0.001)
  • higher post-PCI TIMI-3 flow rates (p < 0.001)
  • Improved wall-motion recovery (WMSI <1.3) (p < 0.001)

Long-term primary endpoint outcomes, including 1-year mortality and unplanned readmissions, are currently being evaluated and are expected to be reported next year.

Together, the Queen of Hearts™ and DIFOCCULT-3 studies provide compelling evidence that AI can enhance clinical decision-making in acute coronary syndromes—from first medical contact to reperfusion. With a strong emphasis on rigorous, multicenter validation and explainable AI, PMcardio continues to set the benchmark for trustworthy, clinically proven AI in cardiovascular care, bridging the gap between innovation and real-world patient impact.

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About TCT Conference

The Transcatheter Cardiovascular Therapeutics (TCT) conference is the largest and most prestigious annual meeting in interventional cardiology, bringing together thousands of clinicians, researchers, industry leaders, and innovators from around the world.

Organized by the Cardiovascular Research Foundation (CRF), TCT has been at the forefront of cardiovascular innovation for over three decades. The meeting serves as the global stage for unveiling groundbreaking research, pivotal clinical trial results, and transformative technologies that are redefining the way cardiovascular disease is diagnosed and treated.

PMcardio Reports Positive RCT Results and Late-Breaking Clinical Science for STEMI Detection
PMcardio Reports Positive RCT Results and Late-Breaking Clinical Science for STEMI Detection

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Powerful Medical

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.
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.

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Powerful Medical team receiving the MedTech Innovator 2025 Mid-Stage Grand Prize award on stage, holding a large winner’s check.

Powerful Medical Wins MedTech Innovator 2025

Powerful Medical has been named MedTech Innovator 2025, winning MTI’s Mid-Stage Grand Finals—top honor from the world’s largest medtech accelerator. The award recognizes PMcardio and its FDA Breakthrough-designated Queen of Hearts™ AI ECG technology, which doubles sensitivity for detecting severe heart attacks and significantly cuts ECG-to-balloon time in large clinical trials.

Independent RCT and Late-Breaking Science: PMcardio to Take Center Stage at TCT 2025

We’re proud to share that PMcardio and the Queen of Hearts™ (STEMI AI ECG model) will be prominently featured at Transcatheter Cardiovascular Therapeutics (TCT) 2025, the largest interventional cardiology conference in the U.S., taking place October 25–27, 2025 in San Francisco, California.

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

All Supported ECG Findings

Rhythms
Sinus bradycardia • Sinus rhythm • Sinus tachycardia • Paced rhythm • Atrial fibrillation
Atrial fibrillation with rapid ventricular response • Atrial fibrillation with slow ventricular response • Atrial flutter • Atrial flutter with rapid ventricular response • Atrial flutter with slow ventricular response • Supraventricular tachycardia • Suspected junctional rhythm • Suspected junctional bradycardia • Suspected accelerated junctional rhythm • Wide QRS rhythm • Idioventricular rhythm • Wide QRS tachycardia

Myocardial Infarctions
  • STEMI
  • STEMI
    Equivalent
Detects occlusive myocardial infarctions (OMIs) even without ST elevation (i.e. posterior STEMI, hyperacute T-waves, etc.). Negative for STEMI mimics (i.e. early repolarization, LVH, etc.)
  • High-Risk NSTEMI
    Represents a type 1 myocardial infarction caused by a transiently recanalized coronary occlusion—classically seen in patterns such as Wellens type A or B due to subtotal LAD obstruction, but possible in any infarct-related territory.
  • Culprit Detection
    AI-predicted likelihood scores for LAD, LCx, and RCA with 3D heart visualization highlighting the predicted culprit artery.

Conduction Abnormalities (Heart Blocks
1st degree AV block • 2nd degree AV block, type Wenckebach • Higher degree AV block • Complete right bundle branch block • Incomplete right bundle branch block • Complete left bundle branch block • Incomplete left bundle branch block • Nonspecific intraventricular conduction delay • Left anterior fascicular block • Left posterior fascicular block • Bifascicular block (RBBB + LAFB) • Bifascicular block (RBBB + LPFB) • Trifascicular block (RBBB + LAFB + AVBLOCK1) • Trifascicular block (RBBB + LPFB + AVBLOCK1)

LVEF
Reduced LVEF (≤40%) • Mildly reduced LVEF (41 – 49%) • No signs of reduced LVEF (≥50%)

Axis
Left cardiac axis deviation • Right cardiac axis deviation • Extreme cardiac axis deviation • Normal axis

Measurements
Heart rate • P wave • PR interval • QRS duration • QT interval • Corrected QT interval (Framingham formula) • RR interval • PP interval • ST elevations

Other Supported Diagnoses
Suspected long QT syndrome • Suspected short QT syndrome • Suspected atrial enlargement • Suspected ventricular hypertrophy • Premature complexes

Dr. Tom De Potter, MD

Cardiologist at the Cardiac Center Aalst

Cardiologist specializing in Pacemaker Device Therapy and Electrophysiology. Leads the electrophysiology unit at the Heart Center in Aalst, holds an executive board position at the European Heart Academy, and serves as EHRA scientific program committee co-chair.

Dr. Martin Penicka, MD, PhD

Cardiologist at the Cardiac Center Aalst

Cardiologist at the Cardiac Center Aalst since 2009, specializing in non-invasive imaging and valvular disease. Fellow of the European Society of Cardiology (FESC) and the European Association of Cardiovascular Imaging (FEACVI).

Dr. Ward Heggermont, MD, PhD

Co-director at the Cardiovascular Center

Co-director at the Cardiovascular Center of Aalst Hospital, specializing in heart failure. Research focus at the intersection of cardiology, virology, and metabolism.

Prof. Dr. Robert Hatala, PhD

Co-founder and Chief Scientist

Head of the Arrhythmia and Pacing department at the National Institute of Cardiovascular Diseases in Slovakia. More than 150 publications and 10,000 citations. Contributor to ESC clinical practice guidelines and executive editor of the European Heart Journal since 2020.

Arieh Levy

Head of PMcardio for Individuals

Arieh leads the PMcardio for Individuals product at Powerful Medical, guiding its development as a clinical tool for emergency physicians, cardiologists, and primary care physicians. He holds a First Class MEng in Biomedical Engineering from Imperial College London, where he specialised in AI for cardiology, building physics-informed neural networks to model atrial electrical properties, giving him a background that bridges the clinical and technical demands of building a certified AI medical device used at the bedside every day.

Dr. Dave Pearson, MD​

Chief Medical Officer

Academic emergency medicine physician, entrepreneur, investor, and researcher with nearly two decades at Atrium Health, one of US largest health systems. Brings expertise at the intersection of clinical care, healthcare innovation, and strategic leadership.

Prof. Stephen W. Smith, MD

Professor of Emergency Medicine

Faculty physician in Emergency Medicine at Hennepin County Medical Center and Professor of Emergency Medicine at the University of Minnesota. Co-inventor of the OMI paradigm and editor of Dr. Smith’s ECG Blog, the most-visited US-based ECG interpretation blog.

Prof. Emanuele Barbato, MD, PhD

President of EAPCI

Interventional cardiologist specializing in coronary artery disease and coronary physiology. Acting president of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and contributor to the clinical practice guidelines for STEMI care.

Scott Sharkey, MD

Chief Medical Officer

Chief Medical Officer of the Minneapolis Heart Institute Foundation and practicing cardiologist at Allina Health Minneapolis Heart Institute. Co-founder of the STEMI Midwest consortium and Takotsubo cardiomyopathy research program and a widely published clinical investigator in STEMI care.

Prof. Dr. Leor Perl, MD

Director of Cardiac Catheterization Institute

Director of Complex Cardiac Interventions and Chief Innovation Officer at Rabin Medical Center. Graduate of the Stanford Biodesign Program.

Suzanne J. Baron, MD, MSc

Director of Interventional Cardiology Research

Director of Interventional Cardiology Research at Massachusetts General Hospital. Holds a Master’s degree in health economics from Harvard School of Public Health. Expert in cardiovascular device impact on healthcare costs and patient-reported outcomes.

Prof. Marco Valgimigli, MD

Deputy Chief Cardiocentro Ticino Institute

Head of Cardiology at Cardiocentro Ticino and Principal Investigator of the TITAN-OMI randomized controlled trial. His research has shaped both European and US clinical practice guidelines on coronary stents, antithrombotic therapy, and vascular access.

Timothy D. Henry, MD

Medical Director of The Carl and Edyth Lindner Center

Leading expert in interventional cardiology and STEMI treatment. Co-founder and principal investigator of the Midwest STEMI Consortium, a registry of more than 20,000 consecutive STEMI activations. Presenting author for the TCT 2025 Late-Breaking Clinical Science on Queen of Hearts.

Matus Horvath

Head of People

Matus leads hiring strategy and culture at Powerful Medical. He previously ran the People Team at Slido, the Slovak SaaS startup later acquired by Cisco — an experience that informs how he builds a high-performing, values-driven team through rapid scaling.

Dr. Timea Kisova, MD

Clinical Research Lead

Timea leads Powerful Medical’s global external validation studies, including the multi-country AI ECG TIMI Study. With a background in biomedical sciences and a medical degree from Barts and The London School of Medicine and Dentistry, she brings the clinical discipline required to generate the prospective, real-world evidence behind every PMcardio module.

Dr. Anthony Demolder, MD, PhD

HF Pathway Lead

Research physician with a PhD on arrhythmias in heritable thoracic aortic disease. He has led international studies at the intersection of cardiology and AI — including earlier work on atrial fibrillation at AZ Sint-Jan Brugge — and now drives Powerful Medical’s heart failure pathway and LVsense™ AI model development.

Dr. Pendell Meyers, MD

ACS Pathway Lead

Emergency medicine physician, prolific educator, and Co-Editor of Dr. Smith’s ECG Blog. He is one of the leading voices behind the Occlusion Myocardial Infarction (OMI) paradigm, the clinical framework that reshaped how heart attacks are identified from the ECG — and which sits at the core of the Queen of Hearts™ model.

Adam Dej

Head of PMcardio for Organizations Engineering

Adam leads engineering for PMcardio for Organizations at Powerful Medical, driving platform architecture, backend systems, and infrastructure behind one of the company’s key growth products. He began programming at 13, entered professional IT at 17, and studied computer security at Comenius University’s Faculty of Mathematics, Physics and Informatics. Known for technical depth across distributed systems, infrastructure, and security, he builds scalable and resilient software with a sharp focus on customer impact. He also champions responsible use of AI and LLMs as force multipliers for modern engineering teams.

Gabriela Rovder Sklencarova

Head of Infrastructure

Gabriela designs the scalable, secure, distributed systems that keep PMcardio running around the clock for clinicians worldwide. She joined from Google, where she was a senior software engineer building core libraries that kept Google’s services resilient against billions of requests, and holds a BA and MA in Computer Science from the University of Cambridge.

Arezou Azar

VP Regulatory

Arezou leads Powerful Medical’s global regulatory strategy across the FDA, EU MDR, and international frameworks. She has been part of nearly every major breakthrough in AI cardiology and is an expert in US and global regulatory strategy, SaMD/digital health launches, with experience at Eko Health, Verily, AliveCor, Cardiologs, and Apple. She specializes in regulatory strategy in high-paced global organizations.

Adam Rafajdus

Head of AI

Adam grew into the Head of AI role from MLOps Engineer over six years at Powerful Medical, bringing deep expertise in deep learning and production-grade system deployment. He leads the team behind the Queen of Hearts™ AI ECG models and was awarded Best Poster at ISCE 2025 for the company’s ECG digitization pipeline.

Mike Wall

VP of Sales

Mike brings more than twenty years at UnitedHealth Group to the table, where he served health plans, employer groups, and public-sector entities as a consultative healthcare sales executive. He combines market intelligence, clinical insight, and financial acumen — the three ingredients needed to bring AI-powered diagnostics into US health systems at scale.

Amani Farid

Head of Strategic Partnerships

Amani leads partnership strategy with a hands-on approach to integration, unlocking long-term value through collaboration and scale. A University of Chicago Law School-trained attorney and former M&A and capital markets associate at two top international law firms, she brings the rare combination of legal precision and commercial execution refined across nearly a decade at Stryker and as VP of Corporate Development at RapidAI — spanning medtech, digital health, and AI-driven diagnostics.

Michal Martonak

Commercial Lead

A mathematician by training, Michal leads commercial strategy, go-to-market, and strategic partnerships with healthcare providers and clinical institutions worldwide. He previously built Powerful Medical’s data and clinical partnerships function, acquiring the large-scale clinical datasets that underpin the company’s certified AI models.

Dr. Jozef Bartunek, MD, PhD

Co-founder and VP Clinical Strategy

Interventional cardiologist and Co-director of the Cardiovascular Center in Aalst, Belgium — one of the world’s leading heart centers. A Fogarty International NIH Fellow at Harvard Medical School and visiting Professor of Medicine at Catholic University Leuven, he has authored more than 240 peer-reviewed publications in heart failure and structural heart disease, and anchors Powerful Medical’s clinical and research strategy.

Simon Rovder

Co-founder and CTO

Simon began his engineering career at Microsoft and holds a Master’s in Informatics from the University of Edinburgh. He built Powerful Medical’s technology organization from zero, scaling it to a 20+ engineer team and leading the platform architecture that powers a CE-certified Class IIb medical device used in hospitals across Europe.

Viktor Jurasek

Co-founder and CPO

Viktor has spent over a decade designing digital products across healthcare and software and has been the design and product force behind PMcardio since the first prototype. He sets the bar for how a clinical-grade product should feel in a physician’s hands — fast, clear, and trustworthy at the point of care.

Felix Bauer

Co-founder and COO

Felix studied at the Technical University of Munich and was part of the TUM Hyperloop team that repeatedly competed and won in Elon Musk’s SpaceX Hyperloop Pod Competition. He brings a rare combination of engineering rigor, regulatory discipline, and operational excellence to the company, leading operations, compliance, certification, quality management, and global market access since day one.

Dr. Robert Herman, MD, PhD

Co-founder and Chief Medical Officer

Robert is a physician-scientist, served on the Research, Digital and Innovation Committee of the European Society of Cardiology. He bridges the worlds of medicine and artificial intelligence, connecting clinicians, AI researchers, and regulators to translate algorithms into clinical practice. Forbes 30 Under 30 Europe 2024.

Martin Herman

Co-founder and CEO

Martin started coding at 14 and moved to Silicon Valley at 18, founding several companies including a US-based startup before returning to Europe with his brother Robert to build Powerful Medical. He comes from a family of doctors, which shaped his conviction that AI belongs wherever it can genuinely save lives. Forbes 30 Under 30 (Europe 2024).

Heart Attacks are #1 cause of death world-wide and killing about 12 milions people a year.

Clinical Definition of Problem

Contrary to popular belief, a heart attacks isn’t a blockage inside of the heart. A heart attack is a blockage of the coronary arteries supplying the heart muscle with oxygenated blood.

So let’s assume you get a blood clot here — it blocks the blood flow downstream, meaning the heart muscle doesn’t get oxygenated blood and heart tissue downstream starts to die.

Clinical Solution​

The way to fix it is relatively simple – doctors put in a stent that opens up the artery and renews blood flow. The latest clinical practice guidelines recommend that this “stenting” happens within 90 minutes from symptom onset.

If you don’t, even if you put in the stent in later, the heart tissue downstream has already been permanently damaged, which reduces the heart’s ability to pump blood. This is the leading cause of heart failure and increases 1-year mortality by two-fold.

Time is muscle.

You have just 90 minutes to diagnose the patient, bring them to the hospital and put in the stent, otherwise there is permanent damage. So problem is, that 1 in 2 heart attacks get initially misdiagnosed at the first point of contact.

Discover the future of medical work with us.

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