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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 ...
TMCnet1d
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 clinical sites. The Company believes the study's findings support the clinical ...
HeartBeam seeks FDA nod for ECG synthesis software
SANTA CLARA, Calif. - HeartBeam, Inc. (NASDAQ: BEAT), a $56.5 million market cap pioneer in medical technology currently trading at $2.12 per share, has announced the submission of a 510(k) ...
MassDevice13d
AliveCor wins CMS reimbursement for 12-lead ECG
AliveCor announced that CMS included its AI-powered ECG system in a final rule that sets a Medicare payment rate for the ...