# Powerful Medical

> Powerful Medical builds PMcardio, an AI-powered ECG interpretation platform for cardiovascular care. Its core AI model, Queen of Hearts™ (ACS AI ECG Module), detects STEMI and Occlusion Myocardial Infarction (OMI) from a standard 12-lead ECG; the Queen of Hearts™ (ACS AI ECG Module) is CE-marked as a Class II(b) medical device under the EU MDR and has received De Novo authorization from the U.S. Food and Drug Administration (FDA) for marketing in the United States. Powerful Medical also holds FDA Breakthrough Device Designation for the Queen of Hearts™ (ACS AI ECG Module) — a designation that expedites FDA review, separate from and not itself a marketing authorization. PMcardio is used by 100,000+ clinicians across 150+ hospitals worldwide and has been validated in 25+ peer-reviewed studies involving over 40,000 patients.

Regulatory status varies by market and by module: it is a property of an individual AI ECG Module, not of the PMcardio platform as a whole. Certain AI ECG Modules are CE-marked medical devices under the EU MDR, as Class II(b) devices, and are certified for marketing in the European Union and the United Kingdom. The Queen of Hearts™ (ACS AI ECG Module) has received De Novo authorization from the U.S. Food and Drug Administration (FDA) for marketing in the United States, and is the only PMcardio module with FDA authorization. The PMcardio platform itself is not FDA-authorized or CE-marked; other modules — including LVsense™, the LVEF AI ECG Model — are not FDA-authorized and are considered investigational devices in the US, not for clinical use there. Not all modules of the PMcardio platform, and not all features and functionality within a given AI ECG Module, 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.

## Products

- [PMcardio: AI-Powered ECG Interpretation](https://www.powerfulmedical.com/): Homepage introducing PMcardio's AI-powered ECG interpretation platform, used by 100,000+ clinicians across 150+ hospitals.
- [PMcardio for Individuals](https://www.powerfulmedical.com/pmcardio-individuals/): AI-powered ECG interpretation app for point-of-care use by emergency physicians, GPs, nurses, paramedics, and cardiologists.
- [PMcardio for Organizations](https://www.powerfulmedical.com/pmcardio-organizations/): AI-powered cardiac care coordination platform enabling accurate ECG diagnosis, secure data integration, and rapid specialist referral for health systems.
- [PMcardio STEMI AI ECG Model](https://www.powerfulmedical.com/pmcardio-stemi/): Queen of Hearts™ (ACS AI ECG Module), PMcardio's STEMI/OMI AI ECG model — CE-marked as a Class II(b) device under the EU MDR and FDA De Novo authorized for the United States — clinically validated in 15+ peer-reviewed studies across 40,000+ patients to detect true STEMI and reduce false cath lab activations.
- [PMcardio LVEF AI ECG Model](https://www.powerfulmedical.com/pmcardio-lvef/): LVsense™, PMcardio's AI model for detecting reduced left ventricular ejection fraction (LVEF) from a standard 12-lead ECG. LVsense™ is not FDA-authorized and is considered an investigational device in the US — not for clinical use.
- [PMcardio Supported Diagnoses](https://www.powerfulmedical.com/supported-diagnoses/): Full list of the 50+ cardiac conditions PMcardio's AI can detect from a 12-lead ECG, including STEMI/STEMI equivalents, arrhythmias, and conduction disorders.

## Clinical Evidence

- [Clinical Validation](https://www.powerfulmedical.com/research/): Filterable index of 40+ peer-reviewed publications (by pathway: STEMI, Heart Failure, Arrhythmia) validating the Queen of Hearts™ OMI/STEMI AI model.
- [Clinical Research](https://www.powerfulmedical.com/clinical-research/): Powerful Medical's two clinical research initiatives — the External Clinical Research Program for investigator-initiated studies, and the Clinical Research Registry collecting de-identified ECGs and outcomes.
- [European Heart Journal: Clinical Validation Study of the PMcardio OMI AI Model](https://www.powerfulmedical.com/blog/european-heart-journal-clinical-validation-study-of-the-pmcardio-omi-ai-model/): International clinical validation study of PMcardio's Queen of Hearts™ OMI AI model, published in the European Heart Journal – Digital Health.
- [How AZORG Standardized STEMI Care Across Six Hospitals](https://www.powerfulmedical.com/case-studies/how-azorg-standardized-stemi-care-across-six-hospitals/): Case study: AZORG Health System (Belgium, six hospitals) reduced door-to-balloon time by 48 minutes using PMcardio's AI-powered cardiac pathway platform.
- [How Havirov Hospital Improved Cardiac Triage and Outcomes with PMcardio](https://www.powerfulmedical.com/case-studies/how-havirov-hospital-improved-cardiac-triage-and-outcomes-with-pmcardio/): Case study: Havirov Hospital (Czech Republic) improved acute coronary syndrome triage speed and coordination in a six-month PMcardio pilot.
- [De Winter Pattern Identified Before STEMI Criteria](https://www.powerfulmedical.com/pmcardio-stemi/de-winter-pattern-identified-before-stemi-criteria/): Clinical case report: Queen of Hearts™ identified a De Winter T-wave pattern, a STEMI-equivalent sign of acute LAD occlusion, before standard STEMI criteria were met.
- [LAD Occlusion Identified and Activated by Paramedic](https://www.powerfulmedical.com/pmcardio-stemi/lad-occlusion-identified-and-activated-by-paramedic/): Clinical case report: a paramedic used Queen of Hearts™ to identify a precordial swirl pattern and activate the cath lab for an anterior LAD occlusion.
- [Bifascicular Block Identified as STEMI-Equivalent](https://www.powerfulmedical.com/pmcardio-stemi/bifascicular-block-identified-as-stemi-equivalent-by-queen-of-hearts/): Clinical case report: Queen of Hearts™ identified bifascicular block as a STEMI-equivalent pattern signaling proximal LAD occlusion.
- [50% of Heart Attacks Do Not Meet Classic ECG-Based STEMI Criteria](https://www.powerfulmedical.com/pmcardio-stemi/50-of-heart-attacks-do-not-meet-classic-ecg-based-stemi-criteria/): Explains why roughly half of patients with an acute coronary occlusion don't show classic ST-elevation on their first ECG, and how Queen of Hearts™ helps catch these missed cases.
- [25–40% of Cath Lab Activations Are False Positives](https://www.powerfulmedical.com/pmcardio-stemi/25-40-of-cath-lab-activations-are-false-positives/): Explains why 25–40% of cath lab activations from STEMI protocols are false positives, and how Queen of Hearts™ improves specificity without sacrificing speed.

## Regulatory & Trust

- [Regulatory](https://www.powerfulmedical.com/regulatory/): PMcardio's regulatory certifications — AI ECG modules CE-marked as Class IIb medical devices under EU MDR, independently certified by TÜV SÜD; Queen of Hearts holds FDA De Novo marketing authorization in the US; GDPR- and HIPAA-compliant.
- [Indications for Use](https://www.powerfulmedical.com/indications-for-use/): Indications for use split by region — United States (Queen of Hearts™ (ACS AI ECG Module)) and Europe (PMcardio OMI AI ECG Model, PMcardio Core AI ECG Model) — with the accompanying regulatory notes.
- [Security](https://www.powerfulmedical.com/security/): Powerful Medical's information security and data privacy standards, including GDPR compliance, for handling clinical and patient data.
- [Trust Center](https://trust.powerfulmedical.com): Powerful Medical's Trust Center, with detailed compliance documentation and security certifications (SOC 2 Type II, ISO 27001, HIPAA, GDPR).

## Pricing & Access

- [Pricing](https://www.powerfulmedical.com/pricing/): PMcardio pricing plans — Individual, Team, and Organization/Enterprise tiers — for clinicians and health systems.
- [Get Access](https://www.powerfulmedical.com/get-access/): How to get access to PMcardio, for both individual clinicians and enterprise/health-system customers.
- [Contact](https://www.powerfulmedical.com/contact/): Contact Powerful Medical for sales, support, or general inquiries (US and EU offices).

## Learn: ECG & OMI Education

- [What is Occlusion Myocardial Infarction (OMI)](https://www.powerfulmedical.com/blog/what-is-occlusion-myocardial-infarction-omi/): Explains OMI — acute coronary occlusion with insufficient collateral circulation, causing transmural infarction — and how it differs from the STEMI/NSTEMI classification.
- [STEMI ECG Criteria](https://www.powerfulmedical.com/blog/stemi-ecg-criteria/): Overview of the classic ECG criteria used to diagnose ST-Elevation Myocardial Infarction (STEMI).
- [STEMI Equivalents](https://www.powerfulmedical.com/blog/stemi-equivalents/): Explains STEMI-equivalent ECG patterns — hidden indicators of acute coronary occlusion that don't meet classic ST-elevation criteria.
- [STEMI Mimics](https://www.powerfulmedical.com/blog/stemi-mimics/): Explains STEMI mimics — non-ischemic conditions that can produce ECG changes resembling STEMI, leading to false cath lab activations.
- [Sgarbossa Criteria](https://www.powerfulmedical.com/blog/sgarbossa-criteria/): Explains the Sgarbossa criteria for diagnosing OMI in patients with left bundle branch block (LBBB) or ventricular paced rhythms.
- [Wellens' Syndrome](https://www.powerfulmedical.com/blog/wellens-syndrome/): Explains Wellens' Syndrome, a post-occlusion reperfusion ECG pattern signaling impending extensive anterior wall MI if untreated.
- [Hyperacute T-Waves](https://www.powerfulmedical.com/blog/hyperacute-t-waves/): Explains hyperacute T-waves as an early STEMI-equivalent ECG sign of acute coronary occlusion.
- [Unmasking Hyperkalemia: Critical ECG Changes](https://www.powerfulmedical.com/blog/hyperkalemia-ecg-critical-changes/): Explains the ECG changes caused by hyperkalemia (serum potassium >5.0 mEq/L) and why early recognition is critical in emergency medicine.
- [Left Ventricular Systolic Dysfunction (LVSD)](https://www.powerfulmedical.com/blog/left-ventricular-systolic-dysfunction-lvsd/): Overview of LVSD — causes, symptoms, severity, and AI-assisted detection from ECG.
- [AI in Cardiology](https://www.powerfulmedical.com/blog/ai-in-cardiology/): General overview of how AI algorithms are transforming pattern recognition and diagnosis in cardiology.

## Company

- [About Us](https://www.powerfulmedical.com/about/): About Powerful Medical, the company behind PMcardio, providing AI-powered ECG interpretation for cardiovascular care.
- [Scientific Board](https://www.powerfulmedical.com/scientific-board/): Powerful Medical's Scientific Board — the clinicians and researchers overseeing clinical validity and safety of PMcardio's AI models.

## Optional

- [FDA Breakthrough Device Designation](https://www.powerfulmedical.com/blog/powerful-medical-receives-fda-breakthrough-device-designation-for-pmcardio-stemi-ai-ecg-model/): Powerful Medical's PMcardio STEMI AI ECG model — the Queen of Hearts™ (ACS AI ECG Module) — received FDA Breakthrough Device Designation for detecting STEMI and STEMI equivalents.
- [Powerful Medical Wins MedTech Innovator 2025](https://www.powerfulmedical.com/blog/powerful-medical-wins-medtech-innovator-2025/): PMcardio named MedTech Innovator 2025 Grand Prize winner ($200,000), the top honor from the world's largest medtech accelerator.
- [€40M IPCEI Grant](https://www.powerfulmedical.com/blog/powerful-medical-receives-40-million-non-dilutive-grant-to-accelerate-early-diagnosis-of-cardiovascular-diseases-with-ai/): Powerful Medical selected to receive over €40 million in non-dilutive funding from the European Commission's IPCEI Tech4Cure initiative.
- [Roche Partnership](https://www.powerfulmedical.com/blog/pmcardio-expands-heart-attack-detection-to-patient-bedside-through-roche-cobas-pulse-point-of-care-platform/): Powerful Medical partnered with Roche to integrate PMcardio's AI ECG interpretation into the cobas® pulse point-of-care platform.
- [PMcardio Reports Positive RCT Results at TCT 2025](https://www.powerfulmedical.com/blog/pmcardio-reports-positive-rct-results-and-late-breaking-clinical-science-for-stemi-detection/): PMcardio's AI-powered ECG technology showed improved heart attack detection and fewer false activations in results presented at TCT 2025, including the DIFOCCULT-3 RCT.