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 ...

for the Company’s groundbreaking 12-lead electrocardiogram (ECG) synthesis software designed for the assessment of rhythms and arrhythmias, including sinus rhythm, atrial fibrillation ...

AFib causes an irregular heart rate that can make your heart feel as if it is fluttering or skipping beats. Panic attacks, on ...

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 ...

Mitchell did mention that current data on some at-home ECG devices indicates a high likelihood of false positive results, ...

24 months after ablation, only 26.5% of patients with advanced fibrosis and short TL were in sinus rhythm compared ... to seek ECG documentation when symptoms suggestive of AF occurred. Recurrences ...

Surface ECG (lead I) and intracardiac electrograms were recorded on ... 4 consecutive QRS complexes with a morphology different from that seen with a normal sinus rhythm, after last stimulated beat.

Mid-cavity LVH with a normal apical ... in patients with HCM in sinus rhythm when LA diameter is >50 mm and bleeding risk is low, while ESC guidelines recommend screening patients with HCM for AF with ...

Sinus tachycardia ... with a single lead ECG channel. This limitation may apply to all arrhythmias except for those causing (pre)syncope, as this will become apparent by a sudden diffuse slowing and ...

The FDA cleared the AliveCor 12-lead ECG system midway through last year. CMS assigned the AI-powered technology to Ambulatory Payment Classification (APC) 5733. This enable hospital outpatient ...