Powerful Medical Secures CPT Code for AI-Powered Heart Attack Detection Following FDA Authorization of Queen of Hearts™

Powerful Medical Secures New CPT Code for Queen of Hearts AI ECG Technology to Detect Heart Attacks

Powerful Medical, a company specializing in artificial intelligence (AI)-driven cardiovascular diagnostics, has announced that the American Medical Association (AMA) CPT® Editorial Panel has established a new Category III Current Procedural Terminology (CPT) code, 1139T, for the noninvasive identification of ST-elevation myocardial infarction (STEMI), STEMI equivalents, and acute or subacute myocardial ischemia through assistive algorithmic analysis of electrocardiograms (ECGs). The new code applies to the service performed using the company’s Queen of Hearts™ technology, which received U.S. Food and Drug Administration (FDA) De Novo authorization in September 2026. The code is scheduled to take effect on January 1, 2027.

The development represents an important step toward integrating AI-assisted heart attack detection into the U.S. healthcare reimbursement framework. By establishing a dedicated code for this service, the AMA has provided physicians and hospitals with a standardized mechanism to report the use of algorithmic ECG analysis for identifying potentially life-threatening cardiovascular conditions.

CPT codes serve as a common language for reporting medical procedures and services across the U.S. healthcare system. They are used by physicians, hospitals, and other healthcare providers when submitting claims to Medicare and commercial health insurance companies. The introduction of code 1139T is expected to support the collection of standardized claims data that payers can use when evaluating coverage policies and reimbursement decisions for AI-assisted ECG analysis.

For Powerful Medical, the new code represents a significant regulatory and commercial milestone as the company works to expand the availability of Queen of Hearts across U.S. hospitals. Although establishing a CPT code does not automatically guarantee insurance coverage or payment, it provides an important foundation for pursuing reimbursement pathways and broader clinical adoption.

New CPT Code Creates a Standardized Reporting Pathway

The newly established Category III CPT code 1139T covers the noninvasive identification of STEMI, STEMI equivalents, and acute or subacute myocardial ischemia through assistive algorithmic analysis of an ECG.

The code will become effective on January 1, 2027, allowing physicians and hospitals to report the service through a dedicated billing classification. It is intended to be reported in addition to the standard 12-lead ECG CPT codes 93000, 93005, and 93010, which cover different components of electrocardiographic services.

The distinction is important because the new code identifies the additional service associated with AI-assisted interpretation for detecting specific acute cardiovascular conditions rather than replacing the conventional ECG procedure itself.

Standardized coding can help healthcare providers document the use of emerging technologies and enable payers to evaluate how these services are used in clinical practice. Claims submitted under a dedicated code may contribute to the evidence base considered by insurers when assessing the clinical utility, utilization, and potential payment structures for a medical service.

Felix Bauer, COO and co-founder of Powerful Medical, highlighted the significance of the development following the FDA’s authorization of Queen of Hearts.

“In September, the FDA authorized Queen of Hearts. From January, U.S. hospitals and physicians will have a dedicated code to report the work it does,” Bauer said. “A CPT code is the first step toward coverage and reimbursement, and we are actively working to secure the relevant reimbursement pathways to support adoption across the United States.”

The company is pursuing the reimbursement pathways needed to support the implementation of its technology across healthcare organizations. The new code provides a standardized reporting mechanism, while actual coverage and payment will depend on the policies and decisions of individual payers and other applicable reimbursement requirements.

Addressing Gaps in Conventional Heart Attack Detection

Heart attacks remain a major public health concern in the United States, where someone experiences a heart attack approximately every 40 seconds. Rapid recognition of an acute myocardial infarction is essential because delays in diagnosis and treatment can increase the risk of heart muscle damage and other serious complications.

Electrocardiography is one of the primary diagnostic tools used when patients present with symptoms suggestive of an acute coronary syndrome (ACS). A conventional 12-lead ECG records the heart’s electrical activity and can reveal patterns associated with myocardial ischemia or infarction.

One important limitation, however, is that not all acute coronary occlusions produce the classic ST-segment elevation pattern traditionally associated with STEMI. Some patients with serious coronary artery blockages present with other ECG findings that may be less readily recognized using standard STEMI criteria.

These presentations are commonly described as STEMI equivalents. They can indicate an acute coronary event requiring urgent assessment and treatment, even when the ECG does not display the characteristic ST-segment elevation pattern.

According to Powerful Medical, up to four in ten acute coronary occlusions may not demonstrate the classic ST-elevation pattern on which conventional ECG criteria rely. Such cases can be difficult to identify during the initial assessment, potentially contributing to delays in specialist evaluation and treatment.

Recognizing these presentations is especially important in emergency departments, where clinicians must make time-sensitive decisions using available clinical information, ECG findings, patient symptoms, and other diagnostic results.

Robert Herman, MD, PhD, chief medical officer and co-founder of Powerful Medical, emphasized the importance of improving recognition of these less typical presentations.

“STEMI equivalents are the heart attacks standard ECG criteria were never designed to find,” Herman said. “Seeing them written into the CPT code set matters to every emergency physician and cardiologist who has watched one of these patients wait.”

The establishment of the new CPT code brings additional attention to the role of algorithmic ECG analysis in identifying potentially serious cardiovascular conditions that may not be apparent through conventional pattern recognition alone.

Queen of Hearts Uses AI to Support Cardiovascular Assessment

Queen of Hearts™ is Powerful Medical’s AI-driven technology designed to assist healthcare professionals in identifying ECG patterns associated with STEMI, STEMI equivalents, and acute or subacute myocardial ischemia.

The technology analyzes electrocardiographic data to help clinicians identify patients with suspected acute coronary syndrome who may benefit from urgent cardiology consultation and potentially early cardiac catheterization.

Cardiac catheterization can be used to investigate coronary artery disease and, when indicated, facilitate procedures such as percutaneous coronary intervention to restore blood flow through an obstructed coronary artery.

In emergency cardiovascular care, identifying patients who require rapid specialist assessment can help clinicians prioritize further evaluation and determine the appropriate next steps. AI-assisted ECG analysis may provide additional decision-support information, particularly in cases where ECG abnormalities are complex or do not fit classic diagnostic patterns.

Queen of Hearts is intended to support clinical decision-making rather than replace the judgment of qualified healthcare professionals. Its findings must be considered alongside the patient’s symptoms, medical history, examination, laboratory results, and other relevant diagnostic information.

The technology’s regulatory progress has been an important component of Powerful Medical’s efforts to establish its role in cardiovascular care. Queen of Hearts received FDA Breakthrough Device Designation before obtaining De Novo authorization in September 2026.

According to the company, the FDA’s De Novo decision established a new device classification for acute cardiovascular event detection and notification software under 21 CFR 870.2390.

De Novo authorization provides a regulatory pathway for certain novel medical devices for which there is no legally marketed predicate device of the appropriate type, provided the applicable statutory and regulatory criteria are met. The authorization allows a qualifying device to be marketed in the United States subject to its authorized indications and applicable requirements.

The FDA’s decision represents a key regulatory milestone for Queen of Hearts as Powerful Medical works to expand its availability in the U.S. healthcare market.

Clinical Evidence Supports Continued Evaluation

Powerful Medical reports that Queen of Hearts is supported by more than 20 peer-reviewed studies, including randomized controlled trials, involving over 40,000 patients across four continents.

This body of research provides clinical evidence supporting the company’s development of AI-assisted ECG analysis for cardiovascular assessment. Studies involving large and geographically diverse patient populations can help researchers evaluate how a technology performs across different clinical settings and patient groups.

Randomized controlled trials are particularly important in clinical research because their design can help investigators assess the effects of an intervention under defined study conditions. Peer-reviewed publications also allow research findings to be evaluated by other experts in the field.

However, the number of studies and patients alone does not establish the precise diagnostic performance or clinical benefit of a technology. Those conclusions depend on the design, quality, endpoints, and findings of individual studies, as well as the populations in which the technology is evaluated.

For healthcare organizations considering AI-assisted ECG analysis, relevant factors include diagnostic accuracy, workflow integration, the ability to identify patients requiring urgent intervention, and the potential impact on clinical decision-making.

Powerful Medical’s stated objective is to help healthcare professionals recognize patients with suspected ACS who may benefit from urgent cardiologist activation and potentially early cardiac catheterization. The technology is designed to provide additional information that can support the clinical assessment of potentially serious cardiovascular events.

The combination of regulatory authorization, published clinical research, and a dedicated CPT code may help the company advance discussions with healthcare providers and payers regarding the implementation of Queen of Hearts in routine care.

Availability Through the PMcardio for Organizations Platform

Queen of Hearts is now available to U.S. hospitals through Powerful Medical’s PMcardio for Organizations platform. The platform is designed to integrate with existing hospital information technology infrastructure, supporting the deployment of AI-assisted cardiovascular analysis within healthcare organizations.

Integration with established hospital systems is an important consideration for medical AI adoption. Hospitals must ensure that new technologies can fit into existing clinical workflows, support timely access to relevant information, and meet applicable technical, security, and operational requirements.

In emergency care, the practical value of a diagnostic-support technology depends not only on its analytical capabilities but also on how effectively it can be incorporated into the clinical decision-making process.

By making Queen of Hearts available through its organizational platform, Powerful Medical aims to support the use of AI-assisted ECG analysis in hospital settings where rapid cardiovascular assessment is essential.

The new CPT code may further support these efforts by giving providers a standardized method to document the additional service associated with algorithmic ECG analysis. As hospitals begin using the code after its effective date, the resulting claims data may help inform future discussions about utilization, coverage, and payment.

Nevertheless, healthcare organizations will need to consider individual payer policies and reimbursement requirements before assuming that the service will qualify for payment. The creation of a CPT code establishes a reporting pathway, not automatic reimbursement across Medicare and commercial insurance plans.

Additional information about Powerful Medical and its cardiovascular diagnostic technologies is available on the company’s website at www.powerfulmedical.com.

A Milestone for AI-Enabled Cardiovascular Diagnostics

The establishment of CPT code 1139T marks a notable development for Powerful Medical as it advances Queen of Hearts from regulatory authorization toward broader adoption in U.S. healthcare settings.

By creating a dedicated reporting code for AI-assisted identification of STEMI, STEMI equivalents, and acute or subacute myocardial ischemia, the AMA CPT Editorial Panel has established a standardized mechanism for documenting this service. The code’s effective date of January 1, 2027, gives healthcare providers a defined timeline for incorporating it into their reporting practices.

For clinicians, the technology addresses an important diagnostic challenge: identifying potentially dangerous coronary events that may not present with classic ST-segment elevation on an initial ECG. For hospitals, the new code offers a way to report the additional algorithmic analysis separately from standard 12-lead ECG services. For Powerful Medical, it provides a foundation for pursuing coverage and reimbursement arrangements that could support wider implementation.

The next phase will involve advancing payer engagement, supporting hospital adoption, and determining how the technology is used in real-world clinical settings. The extent of reimbursement and adoption will depend on payer decisions, healthcare provider requirements, and the evidence supporting the service’s clinical and operational value.

As AI continues to develop across medical diagnostics, the integration of regulatory authorization, clinical evidence, standardized coding, and healthcare IT compatibility will remain important to translating technological innovation into practical clinical applications.

Powerful Medical’s latest announcement positions Queen of Hearts for further expansion within the U.S. cardiovascular diagnostics market, with the new CPT code providing an important administrative step toward potential reimbursement. The company’s broader objective is to help clinicians recognize serious cardiac events earlier and support timely specialist evaluation for patients who may require urgent intervention.

About Powerful Medical

Powerful Medical is leading the AI revolution in cardiology, making expert-level cardiac diagnosis available to every patient, regardless of where they present. Its platform, PMcardio, embeds AI ECG models that detect acute heart attacks (Queen of Hearts™, FDA-authorized and CE-marked) and, in the EU, heart failure, structural heart disease, and 40+ other cardiac conditions. PMcardio is used by more than 100,000 clinicians across hospitals, EMS, and cardiac centers worldwide.

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