HeartBeam Achieves Major Milestone with FDA Submission for its Groundbreaking 12-Lead ECG Synthesis Software
HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for the Company’s groundbreaking 12-lead electrocardiogram (ECG) synthesis software designed for the assessment of rhythms and arrhythmias, including sinus rhythm, atrial fibrillation, atrial flutter, bradycardia, tachycardia, and sinus with premature ventricular contraction (PVC) or premature atrial contraction (PAC).
The FDA submission is backed by robust data from the VALID-ECG pivotal study, which enrolled 198 patients across five clinical sites. The Company believes the study's findings support the clinical equivalence of HeartBeam's synthesized 12-lead ECG where the leads are similar to standard 12-lead ECGs for rhythm and arrhythmia assessment.
The submission builds on HeartBeam’s recent FDA clearance for its patented technology which captures the heart’s electrical signals from three distinct directions. The software synthesizes these signals into a familiar 12-lead ECG using a personalized transformation matrix.
Upon FDA clearance for the software, the Company plans to initiate commercial launch leveraging the learnings and feedback gained from its Early Access Program. Hundreds of physicians and patients have already joined the waitlist underscoring the widespread interest in a powerful and convenient cardiac monitoring option that can be used outside of a medical facility.
Robert Eno, Chief Executive Officer of HeartBeam, commented, “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.”
Additional future planned advances include the integration of AI-based classification algorithms and detection of heart attacks to aid in reducing “symptom to door” times – an area of major focus for the American Heart Association (AHA) to shorten the time from heart attack symptom onset and treatment. HeartBeam believes its groundbreaking technology presents a transformative opportunity to bring about a paradigm shift in cardiovascular care for millions of patients globally.