HeartBeam has submitted a 510(k) application to the US Food and Drug Administration (FDA) for its 12-lead electrocardiogram (ECG) synthesis software tailored to assess various cardiac rhythms and ...

One can either use calculated sums of the amplitudes of QRS complexes of all 12 leads, or the 6 limb leads, or only leads I and II. As noted above, the precordial leads are unreliable ...

The software synthesizes these signals into a familiar 12-lead ECG using ... atrial fibrillation, atrial flutter, and sinus with premature ventricular contraction (PVC) or premature atrial ...

Cardiac arrest and death can occur from ventricular fibrillation ... This is depicted below, followed by full 12-lead ECG examples of digoxin toxicity, atrial tachycardia with 2:1 block and ...

Longstanding persistent AF lasts for more than 12 months ... This paradoxical increase in ventricular heart rates may lead to ventricular fibrillation (ventricular rates of 400 to 600 bpm ...

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 ...