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 clinical sites. The Company believes the study's findings support the clinical ...
Arrhythmias evaluated include sinus rhythm, atrial fibrillation, atrial flutter, and sinus with premature ventricular contraction (PVC) or premature atrial contraction (PAC). About HeartBeam ...
An assessment was made of cardiac function by means of right heart catheterization before and immediately after conversion of atrial fibrillation to sinus rhythm in 11 studies on 10 human subjects.
Mitchell did mention that current data on some at-home ECG devices indicates a high likelihood of false positive results, ...
Sinusitis can cause facial pressure, sinus headache, and other symptoms. Treatment may depend on the cause. A sinus infection, also known as sinusitis or rhinosinusitis, occurs when your nasal ...
Few specific supraventricular rhythm disturbances other than sinus tachycardia were documented ... study reported bigeminal rhythms and PVCs. By contrast, the case report literature reported ...