Bottom line
Queen of Hearts is the acute coronary syndrome module of PMcardio, sold by Powerful Medical from New York and Bratislava. It reads an image or file of any 12-lead ECG and flags STEMI and the STEMI-equivalent occlusion patterns that standard ST-elevation criteria miss. On September 3, 2026 the FDA granted it De Novo authorization under the name "STEMI AI ECG Model". The company positions it as decision support for pre-hospital EMS, emergency departments and hospitals, and in the one published reader study it scored 88.9 percent against about 65 percent for physicians on STEMI-equivalent and mimic ECGs. A clinic that wants routine ECG interpretation is looking at the wrong module, since that is PMcardio's separate Core Diagnostics product with 36 diagnoses.
FDA De Novo authorized AI ECG model that flags STEMI and STEMI-equivalent occlusion MI on any 12-lead ECG, in the PMcardio app and in health-system STEMI pathways.
Pricing from from EUR 10/mo. HIPAA + SOC 2 Type II attested.
What did the FDA authorize?
The De Novo record DEN250044 names the device "STEMI AI ECG Model", lists Powerful Medical, Inc. at 33 W 17th Street, New York, shows the request received on September 22, 2025 and granted on September 3, 2026, and notes an authorized Predetermined Change Control Plan. The company markets the same model as Queen of Hearts and calls the grant "the first FDA De Novo authorization specifically for AI-ECG detection of ACS that requires urgent cardiologist review". The FDA had given it Breakthrough Device designation in March 2025. In Europe the module is CE marked as a Class IIb device under the MDR and certified for the EU and UK. The company's LVsense module for reduced ejection fraction is investigational in the US and not for clinical use there.
The model reads one ECG at a time, so serial comparison is not supported, and the company describes it as a locked algorithm that does not retrain in use. It accepts 12-lead recordings as a single-page image or a multi-page report. One-, three- and six-lead recordings are not supported.
What does the evidence say?
The strongest published test is a 2025 comparative study in the American Journal of Emergency Medicine. Fifty-three emergency physicians and 42 cardiologists interpreted 18 ECGs, eight STEMI equivalents and eight mimics plus one STEMI and one normal ECG, to decide whether an occlusion MI needed immediate cath lab activation. Emergency physicians were right 65.6 percent of the time and cardiologists 65.5 percent. Queen of Hearts scored 88.9 percent, with a 95 percent confidence interval of 82 to 93. Physicians most often misread de Winter patterns, transient STEMI, hyperacute T waves and bundle branch block ECGs. The model misclassified a left bundle branch block with occlusion and a ventricular aneurysm without one. The authors ask for prospective validation.
A 2025 Cureus case report describes a man in his seventies with a new bifascicular block and anterior ST elevation, a proximal LAD subocclusion on angiography, and an app reading of STEMI equivalent. Two further studies test other PMcardio functions. AMSTELHEART-1 (2023) ran the photographed-ECG app on 290 Dutch primary-care patients against a blinded expert panel and found 86 percent sensitivity and 92 percent specificity for any major abnormality, with 97 and 99 percent for atrial fibrillation. A 2025 Journal of Electrocardiology study of 116 hospitalized COVID-19 patients reported sensitivity and specificity of 1.00 for atrial fibrillation against a cardiologist's read.
The company's own figures are larger. It claims twice the sensitivity and 81 percent fewer false positives than standard STEMI criteria, a 92 percent cut in false-positive cath lab activations, an AUC of 0.938 and 48 minutes of door-to-balloon time saved at AZORG, a six-hospital case study. It counts 15 or more peer-reviewed studies on the product page and more than 20 in its press release, covering more than 40,000 patients, and lists the DIFOCCULT-3 randomized trial of 6,000 patients, started in October 2024 with recruiting completed. Those are vendor claims.
What does it cost?
As of November 2026 the pricing page shows prices for the Slovak region in euros and states that pricing varies by country. US list prices are not published.
- Free: five ECGs a month, no credit card.
- Individuals: 10 EUR a month, 17 percent less when billed yearly, 50 ECGs a month, mobile app only, 30-day report history, paid through the app store. The FAQ gives the Pro plan 100 ECGs a month, against 50 on the pricing page.
- Teams: 2,610 EUR a year for 10 users, or 22 EUR per user per month billed yearly, scalable to 50 users, 1,000 ECGs a month, web app, unlimited history, a US or EU data centre and an onboarding session. Each five added users take 5 percent off.
- Organizations: custom pricing with unlimited reports, users and locations, HL7 and XML feeds, EHR integration, the STEMI pathway product, dedicated data residency and an SLA.
Fees are generally non-refundable, and there is no non-profit or educational discount.
How does it fit a hospital pathway?
The company states SOC 2 Type II, ISO 27001, GDPR and HIPAA compliance with a Business Associate Agreement, encryption in transit and at rest, single sign-on, role-based access and audit trails, with data hosted in the US or the EU and a 99.9 percent uptime SLA. PMcardio can be launched from the EHR through secure links and SSO and sends results back to clinical systems. No EHR vendor is named. The company names the ECG device makers GE HealthCare, Philips, Stryker LIFEPAK, corpuls and ZOLL, and supports the AHA Get With The Guidelines registry. It reports more than 100,000 clinicians, 2.5 million ECGs analysed and 150 hospital deployments, and shows Mayo Clinic, Duke Health and Cook County Health among its logos. On its blog the company announces a Category III CPT code, 1139T, for AI ECG heart attack detection from January 1, 2027.
The verdict
An emergency department or EMS service that makes its own cath lab activation decisions is the buyer the company describes, and the reader study, 88.9 percent against 65.5 percent for cardiologists across 18 ECGs, is the evidence it has to show so far. The pathway product with device feeds and EHR launch is where the compliance package, data residency and SLA live, while the 10 EUR app covers one clinician's phone with 50 ECGs a month. A hospital that wants routine interpretation is buying PMcardio's Core Diagnostics, a separate module with 36 diagnoses that this one does not include.
Editorial review last generated November 5, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
