HeartBeam (NASDAQ: BEAT) , a medical technology company advancing cardiac care, has submitted a 510 (k) application to the U.S. Food and Drug Administration (“FDA”) for its 12-lead electrocardiogram ( ...

The atrial fibrillation (AF) device market is experiencing rapid growth, fueled by the rising prevalence of atrial fibrillation, increasing awareness of early diagnosis, and advancements in medical ...

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 ...