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 ...
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 ( ...
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) ...
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 ...
TMCnet15d
New Study Shows AliveCor's Kardia 12L ECG System Performs Equivalently to a Standard 12-Lead ECG
Powered by AliveCor's proprietary KAI 12L AI technology, the pocket-sized Kardia 12L ECG System was designed exclusively for healthcare settings to detect 35 cardiac determinations, including heart ...
Yahoo Finance15d
New Study Shows AliveCor's Kardia 12L ECG System Performs Equivalently to a Standard 12-Lead ECG
The results indicated that Kardia 12L ECG System (with its reduced leadset) performed comparably to the standard 12-lead ECG in detecting major morphology-related abnormalities, including bundle ...
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 ...