TMCnet13d
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 ...
Business Wire13d
HeartBeam Achieves Major Milestone with FDA Submission for its Groundbreaking 12-Lead ECG Synthesis Software
The Company believes the study's findings support the clinical equivalence of HeartBeam's synthesized 12-lead ECG where the leads are similar to standard 12-lead ECGs for rhythm and arrhythmia ...
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 ( ...
Medscape3d
A Comparison of 2-Lead, 6-Lead, and 12-Lead ECGs in Patients With Changing Edematous States
The purpose of this study was to evaluate whether the 12-lead ECG could be substituted by ECG sets with a limited number of leads. Materials and methods: The performance of three ECG systems (ie ...
Morningstar28d
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 ...
BMJ8d
22 Role of 12-lead electrocardiography in predicting heart failure in the community
Purpose Many patients attending their primary care physician with symptoms suggestive of new onset heart failure, have a 12 lead electrocardiogram (ECG) as part of an initial triage work up. However, ...
BioSpace27d
New Study Shows AliveCor’s Kardia 12L ECG System Performs Equivalently to a Standard 12-Lead ECG
The data was also presented at the 2024 CINC Conference in October. Kardia 12L performed comparably to the standard 12-lead ECG in detecting major morphology-related abnormalities. “AliveCor’s Kardia ...
MassDevice25d
AliveCor wins CMS reimbursement for 12-lead ECG
The FDA cleared the AliveCor 12-lead ECG system midway through last year. CMS assigned the AI-powered technology to Ambulatory Payment Classification (APC) 5733. This enable hospital outpatient ...
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) ...
AI proves better than humans at analyzing long-term ECG recordings in large international study
In patients with symptoms such as irregular heartbeats, dizziness, or fainting, or in individuals that physicians suspect may ...
Deep neural network may soon replace invasive procedures as new gold standard for monitoring heart health
The ancient Greek philosopher and polymath Aristotle once concluded that the human heart is tri-chambered and that it was the ...