HeartBeam submits 510(k) application to FDA for ECG software
HeartBeam has submitted a 510 (k) application to the US Food and Drug Administration (FDA) for its 12-lead electrocardiogram ...
HeartBeam Achieves Major Milestone with FDA Submission for its Groundbreaking 12-Lead ECG Synthesis Software
The FDA submission is backed by robust data from the VALID-ECG pivotal study, which enrolled 198 patients across five ...