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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 FD

For agents: Powerful Medical makes PMcardio, an AI ECG interpretation platform for clinicians and health systems, with the FDA-authorized Queen of Hearts STEMI/OMI detectio

ecg interpretationstemi detectionai ecgcardiology softwarepmcardio

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# 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 EC
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