HeartBeam’s 12-lead ECG synthesis software allows patients to obtain an ECG reading for their arrhythmia from the comfort of home, with results promptly reviewed by an on-demand, board-certified cardiologist.
RT’s Three Key Takeaways:
- FDA Clearance – The US FDA granted 510(k) clearance for HeartBeam’s 12-lead ECG synthesis software, enabling a cable-free, at-home ECG solution that synthesizes a visual 12-lead ECG from three-directional signals for physician review of select non-life-threatening arrhythmias.
- Clinical Scope and Convenience – The HeartBeam system allows adult patients to capture clinically meaningful ECG data wherever symptoms occur, but the synthesized 12-lead output is intended only for manual interpretation of specific arrhythmias and does not replace a standard diagnostic 12-lead ECG.
- Growth Strategy – Following clearance, HeartBeam plans a limited commercial launch in early 2026 while advancing heart attack detection, an extended-wear 12-lead patch, and AI-powered longitudinal ECG analytics based on its 3D ECG data platform.
The US FDA has granted 510(k) clearance for HeartBeam Inc’s 12-lead electrocardiogram (ECG) synthesis software for the assessment of arrhythmias.
According to the company, the patented cable-free technology captures the heart’s electrical signals in three non-coplanar dimensions and synthesizes them into a 12-lead ECG representation. This allows patients to obtain an ECG reading for their arrhythmia from the comfort of home, or wherever they happen to be, representing a new level of convenience and peace of mind. The synthesized 12-lead ECG is promptly reviewed by an on-demand, board-certified cardiologist.
Device Info
The HeartBeam System is a portable non-invasive recorder intended to record, store, and transfer a patient’s 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional.
The HeartBeam 12-Lead ECG Synthesis Software synthesizes a 12-Lead ECG from the HeartBeam System 3-Leads (in three-directions) recording device, producing a visual 12-Lead ECG representation that is similar, but not identical, to the same leads of a standard diagnostic 12-Lead ECG. The synthesized 12-Lead ECG output is solely intended for manual assessment of normal sinus rhythm and the following non-life-threatening arrhythmias: sinus arrhythmia, sinus tachycardia, sinus bradycardia, atrial premature complexes, atrial fibrillation, and ventricular premature complex. The synthesized 12-Lead ECG output is not intended for the assessment of any other arrhythmia or conditions (including but not limited to: other atrial arrhythmias, ventricular arrhythmias, hypertrophy, conduction disorders, myocardial infarction or ischemia, pacemaker functions, localization of arrhythmia foci, ECG wave abnormalities, and/or any other disorder). The software does not conduct cardiac analysis and is not intended to replace a standard 12-Lead ECG. The 12-Lead ECG Synthesis Software is intended for adult use only.
With this FDA clearance, the Company intends to advance several key initiatives as part of its growth strategy:
- Limited Launch: Initiate a market introduction in early 2026, focusing on select concierge and preventive cardiology groups that have proactively signaled strong interest in adopting HeartBeam’s technology. This limited market release will enable the Company to validate real world performance and establish reference sites for broader commercialization.
- Heart Attack Detection: Pursue a heart attack detection indication, supported by compelling proof-of-concept data and representing a major expansion opportunity to tens of millions of patients in the U.S.
- Extended Wear Patch: Advance the on-demand 12-lead ECG extended wear monitor project. The Company has developed a working prototype of its novel 12-lead patch, which has the potential to be a best-in-class offering in an existing multi-billion-dollar market with reimbursement.
- Longitudinal Data: Unlock the power of the unique data-rich repository generated from our 3D ECG platform. As adoption grows, the ability for patients to record synthesized 12-lead ECGs over time will create the opportunity to build AI-based screening and prediction algorithms that go beyond what is possible with single-timepoint ECGs or traditional wearables.
Robert Eno, Chief Executive Officer, HeartBeam commented, “The Company wishes to thank the FDA for its expeditious and constructive engagement throughout the review and appeal process, as well as its thorough evaluation of HeartBeam’s clinical data.
“This FDA clearance is a defining moment for HeartBeam, and the true beginning of our mission to revolutionize cardiac care. We look forward to initiating our U.S. market introduction while advancing our efforts on heart attack detection, an on-demand 12-lead extended wear patch, and AI-based screening and prediction algorithms trained on our unique longitudinal data.”
Cardiologist and HeartBeam scientific advisory board member Robert A. Harrington MD, added, “One of the biggest challenges in cardiology is that cardiac symptoms most often don’t happen in the doctor’s office—they happen at home, at night, at work. The ability for patients to collect clinically meaningful ECG data at that exact moment, not hours later, can allow physicians to gain a much clearer understanding of a patient’s condition and take more timely action. HeartBeam is designed to be easy to carry and easy for patients to use, representing an important step forward in cardiac care.”
The Company plans to initiate a limited US commercial launch in Q1 2026 with select concierge and preventive cardiology practices that have already signaled strong adoption interest. Additional details on broader geographic rollout, wearable integration, AI-enabled automated insights, and the Company’s heart attack detection program will be announced in the near future.
Notes from HeartBeam
Full safety information is available via the device’s Instructions for Use or Clinician Portal Manual. (PDFs)
Source: HeartBeam Inc
