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 ...

Furthermore, the proportion of time in sinus rhythm whilst on assigned antiarrhythmia therapy did not effect these outcomes in the 1,316 patients for whom electrocardiograms were available.