HeartBeam (NASDAQ:BEAT) has announced the submission of a 510(K) application to the FDA for its 12-lead electrocardiogram (ECG) synthesis software, designed to analyze diverse cardiac rhythms and arrhythmias, leveraging data from its pivotal VALID-ECG study.
The company specified that the software’s capabilities include assessing conditions such as atrial fibrillation, sinus rhythm, bradycardia, atrial flutter, tachycardia, and sinus with premature atrial contraction—premature ventricular contractions.
In a statement, Robert Eno, CEO of HeartBeam, remarked, “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.”
