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 ...
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) ...
Biomednewsbreaks 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 ( ...
MassDevice12d
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 ...
Morningstar15d
New Study Shows AliveCor's Kardia 12L ECG System Performs Equivalently to a Standard 12-Lead ECG
Kardia 12L performed comparably to the standard 12-lead ECG in detecting major morphology-related abnormalities. "AliveCor's Kardia 12L ECG System was born from our vision to leverage AI and ...