Frequently Asked Questions

PMcardio offers CE-certified AI ECG Models that read ECGs and offers a comprehensive assessment of 50+ cardiac findings. Clinically validated in 25+ peer-reviewed studies and trusted by over 120,000 clinicians worldwide, it delivers rapid, expert-level interpretations, empowering emergency physicians, GPs, nurses, paramedics, and cardiologists to act with confidence at the point of care.

Certain AI ECG Modules are CE-marked medical devices 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 and functionality of the PMcardio platform may be available in your region.

Yes, your encrypted data never leaves your region. PMcardio is fully GDPR and HIPAA compliant and adheres to the strictest regulatory and security frameworks, including SOC 2 Type II and ISO 27001 certifications. For a detailed overview of compliance, data protection practices, and security protocols, visit the Trust Center.

Yes, PMcardio's AI ECG Modules has been rigorously validated in more than 25 independent, peer-reviewed clinical studies. Across these studies, PMcardio AI ECG interpretation outperformed standard-of-care methods, delivering:

• 2x sensitivity for early STEMI detection (often on the very first ECG)
• Up to 92% fewer false-positive cath-lab activations (JACC: Cardiovascular Interventions, presented at TCT)
• Identifies atrial fibrillation (and other arrhythmias) with 98.3% accuracy — on par with board-certified cardiologists

For more information, the latest published evidence, and ongoing RCTs, please visit the Research page.

PMcardio accepts any commercially available 12-lead ECG — whether a single-page image or a multi-page report. For a reliable read, three things matter: the ECG must be on standard ECG graph paper (the grid where every five 1 mm squares form a heavier 5 mm square); the whole tracing must appear on one continuous grid, not split across intersecting grids; and the image should contain only that ECG's leads, with no leads from other ECGs in the frame. Fewer-lead recordings (1-, 3-, or 6-lead) are not supported.

PMcardio's AI-powered ECG algorithms recognize 50+ distinct findings across four major categories:

• Rhythms & arrhythmias: Atrial fibrillation/flutter, supraventricular or ventricular tachycardia, sinus bradycardia/tachycardia
• Conduction disorders: Left/right bundle-branch block, second- and third-degree AV block
• Ischaemia & infarction: Acute ST-elevation myocardial infarction (STEMI) and STEMI equivalents
• ECG measurements: QTc, PR, QRS and nine additional measurements

Looking for the full, continuously updated list? Navigate to the Full List of ECG Findings Detected by PMcardio AI.

No. PMcardio's AI ECG Models are deterministic, CE-certified medical devices purpose-built for ECG interpretation, not a conversational large language model (LLM).

• Zero hallucinations: The same ECG file always returns the same diagnosis.
• Evidence-based training: Fixed model weights are derived from 4 million+ clinically labelled ECGs with matched patient outcomes.
• Independent proof: Performance has been independently validated in 25+ peer-reviewed validation studies across Europe and the U.S.
• Regulatory oversight: Post-market surveillance and quality-management systems ensure ongoing compliance with Medical Device Regulation.

Learn more about how PMcardio compares to AI chatbots like ChatGPT.

Yes. In six peer-reviewed studies, PMcardio AI ECG Models have demonstrated up to 2x higher accuracy than conventional ECG algorithms used in standard ECG machines (e.g., GE Marquette 12SL, Philips, Glasgow Algorithm).

Learn more about how PMcardio compares to Conventional ECG Algorithms.

Yes. Start with a Free Plan that lets you analyze up to 5 ECGs per month at no cost. When you need more reports and advanced Pro features, you can upgrade to a paid subscription with:

• Larger monthly ECG quota: run as many studies as your workflow demands.
• AI explainability for STEMI: colour-coded highlights show the waveform segments driving each positive diagnosis.
• 12 validated interval measurements: instant PR, QRS, QTc intervals and more.
• 30-day report history: revisit, download, or share any ECG analysed in the past month.

Try PMcardio for free — available now on the Apple App Store and Google Play Store.

PMcardio is available on iOS, Android, and web. Start free with 5 ECGs/month — no credit card required. Download it on the Apple App Store or Google Play.

Certain AI ECG Modules are CE-marked medical devices 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 and functionality of the PMcardio platform may be available in your region.

PMcardio for Organizations is a unified cardiac AI platform supporting the full cardiac care journey — from acute emergency detection through screening, procedural analytics, and longitudinal monitoring. It combines multiple AI models, clinical decision support, real-time escalation, and outcomes intelligence into one deployment, integration, and governance model.

Certain AI ECG Modules are CE-marked medical devices 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 and functionality of the PMcardio platform may be available in your region.

Most cardiac AI tools serve one condition or one modality. PMcardio is a platform spanning the full cardiac pathway — acute care, screening, remote monitoring, procedural analytics, and patient-facing use cases. One integration, one security review, one vendor relationship, one governance model.

PMcardio is organized into six clinical suites spanning the cardiac pathway: Acute Care, Echo Screening, Core Diagnostics, Remote Monitoring, Patient, and Angio. Available today are the STEMI (Queen of Hearts™) and LVEF (LVsense™) models, alongside Core Diagnostics and ECGxplain™. Additional diagnostic capabilities — including PE/RV strain, hyperkalaemia (HyperK), aortic stenosis, HCM, wearable integrations, Holter and coronary angiogram analysis — are in active development and rolling out progressively. Health systems can start with the modules available today and add new ones as they launch.

PMcardio connects to ECG devices, EHR/CVIS, EMS systems, angiographic systems, and existing alerting and on-call tools — with live deployments across leading device manufacturers including GE HealthCare, Philips, LIFEPAK (Stryker), corpuls, and ZOLL. It can be launched from the EHR with secure links and SSO, and sends results back to clinical systems where care is documented.

Immediately — clinicians can start on day one, with no IT integration required: download the mobile or web app, log in, and begin scanning ECGs. Most health systems run a proof-of-concept on real patients within their first weeks. Scaling up — a phased rollout across departments, campuses, and suites with enterprise integrations and EHR connectivity — depends on integration scope and the number of sites and suites, but the platform is built to deliver value before that integration work even begins.

Yes. Most health systems start with one suite — often the Acute Care Suite for STEMI pathway standardization — and expand to additional suites as their priorities evolve. Because everything runs on the same platform, each new suite adds capability without adding vendor complexity.

No. PMcardio's AI ECG Modules provides interpretable, clinically validated decision support designed to augment clinical judgment — not replace it. Clinicians always make the final call. The AI surfaces high-risk presentations and provides explainable reasoning that can be reviewed, taught, and audited.

Results vary by suite and deployment scope. Health systems using the Acute Care Suite have seen 48-minute reductions in door-to-balloon times, 92% reductions in false-positive cath-lab activations, and 6 hours faster treatment for STEMI equivalents. Echo Screening and Remote Monitoring Suites deliver value through earlier detection of previously missed conditions like reduced LVEF and subclinical SHD.

Yes. PMcardio is built for regulated healthcare environments, with SOC 2 Type II, ISO 27001, GDPR, and HIPAA compliance. Certain AI modules within the platform are CE-marked medical devices certified under EU MDR. The platform supports regional data residency, role-based access control, SSO, and full audit trails. Visit the Trust Center for full details.

Yes. PMcardio's mobile and web app lets your team start using AI-powered ECG interpretation immediately — no IT integration, no setup project, no waiting. Clinicians download the app, log in, and start scanning real ECGs from day one. Most health systems run a proof-of-concept on their own patients and see measurable results before moving to a system-wide rollout.

Queen of Hearts (QoH) is a clinically validated AI ECG model designed to accurately distinguish true STEMI (requiring emergent cathlab activation) from common mimics such as benign early repolarization (BER) and left ventricular hypertrophy (LVH). It was trained on a global dataset comprising millions of ECGs from chest pain patients, with robust outcome labels based on biomarker rule-out or angiographically confirmed STEMI, including STEMI-equivalent patterns indicative of Occlusion Myocardial Infarction (OMI).

The Queen of Hearts is a CE-marked medical device under EU MDR and only certified for marketing in the European Union and the United Kingdom. It has not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA and is considered an investigational device in the US. Not for clinical use. Availability of features may vary by region.

Yes, the Queen of Hearts is built into the PMcardio platform, available for individuals or institutions. Download the PMcardio app and get the Queen of Hearts AI interpretation on any image of a 12-lead ECG within seconds.

The Queen of Hearts is a CE-marked medical device under EU MDR and only certified for marketing in the European Union and the United Kingdom. It has not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA and is considered an investigational device in the US. Not for clinical use. Availability of features may vary by region.

Yes — in certain regions. Queen of Hearts is Class IIb medical device, CE-marked under the EU Medical Device Regulation (MDR) and approved for clinical use through the PMcardio platform.

In other regions, such as the United States, where it recently received FDA Breakthrough Device Designation it is currently available for research or investigational use pending FDA approval. Availability of features may vary by region.

For more information on regulatory status and compliance, please visit our Trust center.

Yes. The Queen of Hearts AI model is one of the most clinically validated cardiovascular AI tools to date, having undergone rigorous testing across diverse patient populations. It has been evaluated in thousands of real-world cases across North and South America, Europe, Asia, Australia, and Africa.

Key highlights from validation studies involving over 10,000 patients:

• 2× higher sensitivity than traditional criteria and standard-of-care interpretation
• 92% reduction in false-positive cath-lab activations due to common STEMI mimics (JACC: Cardiovascular Interventions, presented at TCT)
• 100% sensitivity for STEMIs that meet standard STEMI criteria
• Average of 48 minutes saved in door-to-balloon times following implementation

Beyond observational data: Queen of Hearts is currently the focus of multiple prospective clinical trials and randomized controlled studies (RCTs). These are being conducted across a range of clinical settings — including emergency departments, ambulance systems, and primary care — to further confirm its real-world impact, safety, and effectiveness.

Yes. Powered by the exclusive ECGxplain™ feature, Queen of Hearts offers built-in AI explainability (blue heat maps).

The model highlights specific ECG leads and segments that had the greatest diagnostic influence and provides a confidence score for each prediction. This helps you understand the reasoning behind the output, making it easier to interpret.

Learn more about AI explainability here.

Queen of Hearts is a clinical decision support tool, not a standalone diagnostic system. Just like a lab value, guideline recommendation, or scoring system, it provides clinicians with evidence-based insights to support, not replace, their medical judgment.

The responsibility for final clinical decisions remains with the healthcare provider. Physicians are expected to consider the AI output in the broader context of each patient's clinical presentation, history, and other diagnostics.

Re-running Queen of Hearts on serial ECGs helps detect evolving ischemia or dynamic changes. Currently, the AI model analyzes each ECG individually and does not yet compare serial ECGs over time.

However, in a recent study, Queen of Hearts identified 100% of STEMIs on the first ECG, compared to just 40% with traditional STEMI criteria — highlighting its ability to detect early signs of coronary occlusion even without serial input.

The Queen of Hearts is built to detect Occlusion MI (OMI) — acute coronary occlusion that often does not meet the classic STEMI ST-elevation threshold and is therefore missed by traditional criteria. By recognising these STEMI-equivalent patterns, QoH flags patients who need emergent cath-lab activation sooner. In one study it identified 100% of STEMIs on the first ECG versus 40% with traditional criteria.

LVsense™ estimates left ventricular systolic function — how effectively the heart's main pumping chamber contracts — directly from a 12-lead ECG. It flags reduced LVEF, defined as a left ventricular ejection fraction ≤ 40%. Ejection fraction is the share of blood the left ventricle pumps out with each beat; a normal value is roughly ≥ 50%, so ≤ 40% indicates impaired pumping (left ventricular systolic dysfunction), the hallmark of heart failure with reduced ejection fraction. Detecting it earlier helps route patients to timely confirmation and treatment.

A normal left ventricular ejection fraction (LVEF) is generally 50–70%. An LVEF of 41–49% is considered mildly reduced, and 40% or below is classified as reduced. LVsense™ is built to flag the patients most at risk — those with an LVEF of 40% or lower.

Common symptoms include fatigue, breathlessness on exertion, and swelling in the legs or ankles. The difficulty is that these signs are nonspecific and often absent in early disease — a meaningful share of people with reduced LVEF have no symptoms at the stage where treatment could most change their outcome. That silent window is exactly why a point-of-care screen matters.

No. Echocardiography remains the reference standard for measuring LVEF. LVsense™ is a screening signal, not a diagnosis — it helps identify which patients should be prioritized for confirmatory echo. Because a negative result carries a high negative predictive value (99.5% at the prevalence studied), it supports rule-out and helps focus limited echo capacity on higher-probability patients. A positive flag should always be confirmed by echocardiography.

A standard resting 12-lead ECG. No proprietary hardware is required — LVsense™ works from a smartphone photo of a printed or on-screen ECG, which the PMcardio app digitizes before analysis. It is designed to work with ECGs from the wide range of standard devices used in primary care, emergency, and hospital settings. For health systems, PMcardio also integrates with existing clinical infrastructure, so ECGs and results can flow directly to and from the electronic health record (EHR) without disrupting current workflows.

Validated against echocardiography (LVEF ≤ 40% model), LVsense™ achieved an AUC of 0.963, sensitivity of 92.4%, specificity of 88.7%, and a negative predictive value of 99.5%, evaluated on 25,510 echo-paired ECGs. Full methods, the secondary LVEF < 50% model, and peer-reviewed results are available on our publications page.

Availability depends on your region. In the EU and UK, LVsense™ is provided as part of PMcardio's CE-marked AI-ECG modules under the EU Medical Device Regulation (MDR). In the United States, the LVEF AI ECG Model (LVsense™) is an investigational device, has not been cleared or approved by the FDA, and is not for clinical use. Not all PMcardio modules are available in every region.

LVsense™ is available in the PMcardio app — download it from the App Store or Google Play and try it free, with 5 free ECGs per month and no credit card required. Plans for individuals and organisations are listed on the Pricing page; to roll it out across a hospital or network, use Get access to start.

Absolutely. PMcardio for Individuals offers a Free Plan that lets you try out the application with 5 free ECG reports monthly. For PMcardio for Teams or PMcardio for Organizations, we are open to discussing a trial option on a case-by-case basis.

If you wish to upgrade from the free trial (Free Plan) and get the full paid PMcardio for Individuals Pro license, you can do so directly through the PMcardio for Individuals application.

In PMcardio for Individuals, the application won't allow you to surpass the 5 ECGs/month limit in the Free Plan or 100 ECGs/month limit in the paid Pro Plan. You will be notified that you have reached the limit and will need to wait for the quota to reset in your next billing month so that you can continue creating ECG reports.

In PMcardio for Teams, there is a soft cap on the monthly ECG quota. If you considerably surpass the purchased quota, the functionality of your account will be limited, and upon such limitation, you will not be able to create additional reports.

Yes, depending on your use-case. We are happy to discuss it further with you. Please reach out to us at support@powerfulmedical.com.

Yes, we can set up a custom team plan for you. To discuss your specific requirements, please reach out to sales@powerfulmedical.com.

All plans include email support and access to our help center.

In addition, PMcardio for Teams and PMcardio for Organizations get priority email support.

Plus, PMcardio for Organizations includes dedicated Service Level Agreements (SLAs), support, onboarding, and training.

Yes, you can decide to upgrade or downgrade your plan at any time.

For PMcardio for Individuals, you can make changes directly through the application's settings.

For PMcardio for Teams and PMcardio for Organizations, please let us know at sales@powerfulmedical.com.

Currently, we do not provide special discounts for these types of institutions, but we offer a Free Plan under PMcardio for Individuals, and we are also glad to discuss your case on an individual basis via support@powerfulmedical.com.

For the PMcardio for Individuals application, the payment is processed directly through the app store, so it can be any payment method that you have associated with your app store account.

For PMcardio for Teams and PMcardio for Organizations, we will issue an invoice for you, which you can pay by card or via bank transfer.

To discuss any alternative payment methods, please let us know at support@powerfulmedical.com.

Yes. You should be able to get reimbursed by providing PMcardio's invoice (receipt) to your employer. (Note: If you have the PMcardio for Individuals subscription, you should be able to locate and download your receipt directly from your app store account.)

Subscription fees are generally non-refundable; however, refunds may be granted in cases such as an accidental purchase with no use yet, or documented issues preventing proper use of the software. Each request will be reviewed individually to determine eligibility.