HeartBeam Submits 12-Lead ECG Synthesis Software to FDA

HeartBeam has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its 12-lead electrocardiogram (ECG) synthesis software to evaluate rhythms and arrhythmias. These include sinus rhythm, atrial fibrillation, atrial flutter, bradycardia, tachycardia, and sinus with premature ventricular contraction (PVC) or premature atrial contraction (PAC).

This submission adds to the company’s recent FDA nod for its patented tech that captures the heart’s electrical signals from three distinct directions. The software synthesis these signals into a familiar, 12-lead ECG using a personalized transformation matrix.

HeartBeam plans to begin commercial launch upon FDA clearance, using the knowledge and feedback from its Early Access Program. The company said hundreds of clinicians and patients have already joined the waitlist for the cardiac monitoring option that can be used outside of a medical facility.

Future planned advancements for the technology include integrating artificial intelligence (AI)-based classification algorithms and detection of heart attacks to help lower “symptom to door” times to shorten the time from heart attack symptom onset and treatment.

Robert Eno, CEO of HeartBeam, said, “The FDA submission for the 12-lead synthesis software is a significant step as we work towards fulfilling HeartBeam’s vision to offer patients and physicians an easy-to-use portable device and transform how cardiac conditions are monitored and detected.”

Eno was appointed CEO of the company on October 21, 2024.

Data supporting FDA submission

Data from the VALID-ECG pivotal study was used, which finished enrollment in June 2024. The study enrolled 198 patients at five clinical sites.

The data showed similar performance of HeartBeam’s synthesized 12-lead ECG waveforms compared to simultaneously collected standard 12-lead ECGs for arrhythmia detection. The pilot study found excellent agreement when physicians diagnosed various arrhythmias utilizing the HeartBeam synthesized 12-lead ECG compared to a standard 12-lead ECG (sensitivity: 94%, specificity: 100%).