QualityStocksNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Submits FDA Application for 12-Lead ECG Synthesis Software
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 (“ECG”) synthesis software. The software is designed to assess cardiac rhythms and arrhythmias, including atrial fibrillation, atrial flutter, bradycardia, and tachycardia. The submission is supported by data from the VALID-ECG pivotal study, which enrolled 198 patients across five clinical sites and demonstrated clinical equivalence to standard 12-lead ECGs. HeartBeam recently secured FDA clearance for its patented technology that captures heart signals from three directions and synthesizes them into a traditional 12-lead ECG format.…