HeartBeam has submitted a 510(k) application to the US Food and Drug Administration (FDA) for its 12-lead electrocardiogram ...
The FDA submission is backed by robust data from the VALID-ECG pivotal study, which enrolled 198 patients across five ...
Arrhythmias evaluated include sinus rhythm, atrial fibrillation, atrial flutter, and sinus with premature ventricular contraction (PVC) or premature atrial contraction (PAC). About HeartBeam ...