HeartBeam’s 3D ECG Technology Accepted into FDA’s TAP Program to Advance Heart Attack Assessment
HeartBeam, Inc., a medical technology company focused on transforming cardiac care through advanced cardiac insights, announced that the U.S. Food and Drug Administration (FDA) has accepted its HeartBeam System into the agency’s Total Product Life Cycle Advisory Program (TAP) Pilot. The voluntary program is designed to accelerate patient access to innovative medical devices, particularly technologies that have received Breakthrough Device Designation.
The acceptance, which came ahead of schedule, applies to HeartBeam’s three-dimensional electrocardiogram (3D ECG) technology being developed to assess potential heart attacks outside traditional medical settings. The technology received FDA Breakthrough Device Designation earlier in October 2026, marking an important regulatory milestone for the company as it advances its efforts to make clinical-grade cardiac assessment more accessible beyond hospitals and clinics.
HeartBeam’s participation in the TAP Pilot is expected to provide structured engagement with FDA advisors and facilitate early interactions with healthcare providers, patient advocacy organizations, and health insurance payers. These discussions are intended to help address regulatory, clinical, reimbursement, and commercialization considerations throughout the product development process.
For HeartBeam, the combination of Breakthrough Device Designation and TAP participation represents an opportunity to advance its heart attack assessment technology while working with key stakeholders to prepare for potential clinical adoption. The company is prioritizing the development of a solution that could provide physicians with objective ECG information when patients begin experiencing symptoms, including in locations where conventional hospital-based testing may not be immediately available.
FDA TAP Acceptance Strengthens HeartBeam’s Regulatory Strategy
The FDA’s Total Product Life Cycle Advisory Program is intended to support the development of innovative medical devices by establishing earlier and more consistent communication between device manufacturers and the agency. Through the program, participating companies receive access to dedicated FDA advisors who can provide proactive regulatory guidance and coordinate feedback on development plans.
Beyond regulatory discussions, TAP connects medical technology innovators with important stakeholders across the healthcare system. These include patient advocacy groups, healthcare provider organizations, and insurance payers, which can help manufacturers understand the practical considerations affecting patient access and the adoption of new technologies.
Such engagement can be particularly important for devices intended to be used outside conventional healthcare facilities. While a technology may demonstrate technical and clinical potential, its widespread adoption can also depend on whether healthcare professionals understand how to interpret its results, whether patients can access it when needed, and whether payers establish appropriate coverage and reimbursement arrangements.
For HeartBeam, early engagement through TAP could help the company address these considerations while advancing its investigational heart attack assessment capability. The program provides a framework for discussing clinical evidence requirements, regulatory submissions, reimbursement strategies, and potential implementation challenges before the product reaches the market.
HeartBeam said it has already held its first meeting with its assigned TAP advisors and expressed enthusiasm about the level of engagement provided by the FDA.
“Acceptance into TAP, just weeks after Breakthrough Device Designation, gives us a structured partnership with FDA advisors and ongoing access to the stakeholders who will help determine how quickly patients can benefit from our 3D ECG technology for heart attack assessment, our top strategic priority,” said Branislav Vajdic, PhD, Founder and President of HeartBeam.
Vajdic added that the company has begun working with its TAP advisors and believes the engagement could help accelerate its progress toward providing physicians with objective, clinical-grade ECG information when symptoms of a potential heart attack emerge, regardless of the patient’s location.
Although participation in TAP does not guarantee regulatory approval or commercial success, the company views the program as an important component of its broader strategy to advance its cardiac technology.
Addressing the Need for Cardiac Assessment Outside Hospitals
Heart attacks remain a major healthcare challenge, requiring timely assessment and appropriate medical intervention. According to HeartBeam, more than 20 million adults in the United States are at elevated risk of experiencing a heart attack.
The standard 12-lead electrocardiogram is widely used to evaluate patients with suspected myocardial infarction (MI), the medical term for a heart attack. However, access to this testing method is largely concentrated in hospitals, emergency departments, clinics, and other established healthcare settings.
This creates an important development opportunity for technologies that could provide useful cardiac information outside traditional clinical environments. When a patient develops symptoms suggestive of a heart attack, access to appropriate assessment can be influenced by location, transportation, healthcare infrastructure, and the time required to reach a medical facility.
HeartBeam is developing its 3D ECG technology to support heart attack assessment beyond these conventional settings. The company aims to provide physicians with ECG information that could contribute to clinical evaluation when symptoms begin.
The technology is being developed on the same underlying 3D ECG platform used in HeartBeam’s FDA-cleared arrhythmia product. According to the company, it does not currently anticipate needing to develop new hardware for the heart attack assessment capability.
Building on an existing platform could help the company focus its development efforts on the specific clinical application, evidence generation, and regulatory requirements associated with myocardial infarction assessment. Nevertheless, the investigational heart attack indication will require appropriate clinical validation and FDA authorization before it can be marketed for that purpose.
The company’s strategy reflects a broader effort to extend cardiac assessment capabilities beyond centralized healthcare settings. If successfully developed and authorized, the technology could potentially complement existing cardiac evaluation pathways by making ECG information available in additional care environments.
However, the potential role of the HeartBeam System in evaluating suspected heart attacks will depend on the results of future clinical studies and the FDA’s review of the evidence supporting the proposed indication.
Breakthrough Device Designation Supports Development
HeartBeam’s acceptance into the TAP Pilot follows its receipt of FDA Breakthrough Device Designation earlier in October 2026.
The FDA’s Breakthrough Devices Program is intended to help facilitate the development and timely review of certain medical devices and device-led combination products that may provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases or conditions.
For qualifying technologies, the program can provide opportunities for more frequent communication with the FDA and a prioritized review process. The designation is intended to help address development and regulatory challenges while maintaining the standards necessary to establish safety and effectiveness.
HeartBeam’s 3D ECG technology received the designation for its potential role in assessing heart attacks outside a medical setting. The milestone underscores the company’s efforts to develop a cardiac assessment solution that could extend beyond the conventional hospital-based 12-lead ECG model.
The subsequent TAP acceptance adds a broader stakeholder engagement component to this regulatory strategy. While Breakthrough Device Designation can support interaction with the FDA during development and review, TAP is designed to facilitate engagement across the product lifecycle, including considerations related to clinical adoption and patient access.
Together, the two programs provide HeartBeam with additional opportunities to discuss its development plans, regulatory pathway, clinical evidence strategy, and potential reimbursement requirements with relevant stakeholders.
The company believes these interactions could help it prepare for the transition from investigational development to potential clinical use, subject to successful study results and the necessary regulatory decisions.
Early Reimbursement Discussions Could Support Patient Access
In addition to regulatory planning, reimbursement is an important consideration for medical devices intended for broader clinical use. Healthcare providers and patients may face barriers to adopting a new technology if coverage arrangements, payment policies, or evidence requirements are unclear.
HeartBeam’s participation in TAP is expected to support earlier discussions with payers about the evidence and practical considerations that may influence coverage decisions.
The company intends to engage stakeholders while development activities are ongoing rather than waiting until after a potential FDA clearance. These discussions may include interactions involving the Centers for Medicare & Medicaid Services (CMS), depending on the applicable pathway and circumstances.
Early engagement could help HeartBeam better understand what clinical and economic evidence may be needed to support reimbursement discussions. It could also provide an opportunity to identify potential barriers to implementation before the company reaches the later stages of development.
For a technology designed to provide cardiac assessment outside traditional medical settings, reimbursement considerations may be especially relevant. Potential clinical use will depend not only on regulatory authorization but also on whether healthcare systems can incorporate the technology into appropriate care pathways and determine how its use should be funded.
The company is also evaluating whether its device could qualify for the RAPID coverage pathway announced by CMS and the FDA in April 2026.
The Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway is intended to accelerate Medicare beneficiary access to eligible Breakthrough devices. HeartBeam said it is currently evaluating its eligibility for the pathway in consultation with its TAP advisor.
The company has not indicated that eligibility or coverage has been secured. Any potential benefit from RAPID would depend on the applicable criteria, the device’s regulatory status, and the relevant coverage determinations.
Nevertheless, the evaluation reflects HeartBeam’s efforts to consider regulatory authorization and reimbursement planning together as it advances its heart attack assessment program.
Multicenter Pivotal Study Planned for 2027
HeartBeam’s next major development milestone involves establishing the design of a multicenter pivotal clinical study for its investigational heart attack assessment technology.
The company expects to seek FDA alignment on the study design in the coming months. It anticipates beginning patient enrollment in the first quarter of 2027.
The planned study is intended to generate clinical evidence supporting a future regulatory submission to expand the HeartBeam System’s indications to include heart attack assessment.
A pivotal study can play a central role in determining whether an investigational medical device produces sufficiently reliable results for its proposed clinical application. The design, patient population, study endpoints, and evidence requirements will be important considerations as HeartBeam works with the FDA to establish the appropriate framework for evaluating the technology.
The company’s planned regulatory discussions are expected to help clarify the study requirements and align its evidence-generation strategy with the agency’s expectations.
Following the initiation of enrollment, the timing of subsequent milestones will depend on study execution, patient recruitment, data collection, analysis, and regulatory review. HeartBeam has not provided a specific timeline for completing the study or submitting the future application.
If the study produces supportive results and the FDA ultimately authorizes the proposed indication, the company could move closer to making its heart attack assessment technology available for its intended use. Until then, the application remains investigational.
Market Opportunity and Broader Cardiac Platform Strategy
HeartBeam estimates that the market opportunity for its myocardial infarction assessment technology is approximately $15 billion. The company also identifies a broader opportunity of more than $40 billion for its overall cardiac platform.
These estimates reflect the potential commercial scope of cardiac technologies designed to support assessment and monitoring across different clinical needs. The company’s existing FDA-cleared arrhythmia product provides a foundation for its broader platform strategy, while the investigational heart attack assessment application represents a potential expansion into another important area of cardiac care.
Using a shared technology platform may allow HeartBeam to pursue multiple cardiac applications without necessarily requiring entirely separate hardware development for each use case. However, each proposed indication may involve distinct clinical evidence requirements and regulatory considerations.
The estimated market figures represent the company’s assessment of the potential opportunity and should not be interpreted as guaranteed revenue or evidence of future market adoption. Actual commercial performance would depend on regulatory outcomes, clinical utility, competition, pricing, reimbursement, and healthcare provider acceptance.
The company’s near-term focus remains on advancing the heart attack assessment program through regulatory engagement and the planned pivotal study.
Important Regulatory Limitations
Despite the latest milestones, HeartBeam emphasized that enrollment in the TAP Pilot does not change the statutory or regulatory requirements applicable to its device. Participation also does not guarantee that a future submission will receive FDA authorization or that insurance coverage will be granted.
The HeartBeam System is not currently cleared for heart attack detection, and its use in clinical studies for this purpose remains investigational.
The FDA’s acceptance of the technology into TAP should therefore be viewed as a development and engagement milestone rather than a marketing authorization or confirmation of clinical effectiveness for heart attack assessment.
HeartBeam’s progress will depend on its ability to establish an appropriate pivotal study design, enroll patients, generate supportive clinical evidence, and satisfy the FDA’s requirements for the proposed indication.
For now, the company is combining its Breakthrough Device Designation with TAP participation to advance regulatory planning, prepare for clinical evidence generation, and explore potential reimbursement considerations.
With FDA discussions on the pivotal study expected in the coming months and patient enrollment anticipated to begin in the first quarter of 2027, HeartBeam is moving toward the next stage of development for its 3D ECG technology. The outcome of that work will help determine whether the platform can eventually support heart attack assessment outside traditional medical settings and contribute to the company’s broader goal of expanding access to cardiac insights.
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company believes it has developed the first cable-free device capable of collecting ECG signals in 3D, from three non-coplanar directions, and synthesizing the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence.
Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management. HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and the 12-Lead ECG synthesis software received FDA clearance for arrhythmia assessment in December 20251. The Company holds more than 25 issued patents related to technology enablement. For additional information, visit HeartBeam.com.