Medical technology company HeartBeam Inc (NASDAQ: BEAT) announced on Wednesday that it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its innovative 12-lead electrocardiogram (ECG) synthesis software, designed to assess a range of cardiac rhythms and arrhythmias, including atrial fibrillation and bradycardia.

The FDA submission is based on robust data from the VALID-ECG pivotal study, involving 198 patients across five clinical sites. The findings support the clinical equivalence of HeartBeam's synthesized 12-lead ECG with standard ECGs for rhythm and arrhythmia assessment.

This submission follows the company's recent FDA clearance of its patented technology, which captures the heart's electrical signals from three distinct directions and synthesizes them into a 12-lead ECG. Upon clearance, HeartBeam plans to launch the software commercially, building on insights from its Early Access Program.

HeartBeam's technology has already attracted substantial interest from physicians and patients. Future developments include AI-based algorithms for heart attack detection and efforts to reduce "symptom to door" times, a key focus for the American Heart Association.

The company is positioning its technology as a transformative solution for cardiac care, offering portable, non-invasive heart monitoring outside of medical facilities.