AliveCor Announces FDA Clearance of New Cardiac Determinations for Kardia 12L ECG System, Bringing Total to 39

AliveCor, the global leader in AI-powered cardiology, today announced it has received U.S. Food and Drug Administration (FDA) ...
Medical Device Network on MSN

AliveCor secures FDA approval for next-generation Kardia 12L ECG system

The newly cleared features include three rhythm modifiers and two axis-related morphology determinations: RAD and LAD.
Medical Device and Diagnostic Industry (MD+DI)

AliveCor’s Tumultuous Week

While AliveCore faced two wins, the dispute did not end there. In March 2025, Apple triumphed in a major patent dispute with ...
MassDevice

AliveCor earns another FDA nod for AI-powered 12-lead ECG tech

AliveCor announced today that it received FDA clearance for the next generation of its AI technology for the Kardia 12L ECG ...
Healio

Fully automated ECG analysis system gains FDA 510(k) clearance

We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected]. Automated ECG interpretation system gains FDA clearance ...
The Victoria Advocate

Kardia 12L ECG System Receives CMS Reimbursement Approval

MOUNTAIN VIEW, Calif., Jan. 16, 2025 /PRNewswire/ -- AliveCor, the leading innovator in FDA-cleared personal electrocardiogram (ECG) technology, today announced that the Centers for Medicare & ...
MedPage Today

Accurate 6 Lead ECG on Your Smartphone? 'Amazing'

The Skeptical Cardiologist has been evaluating a demo version of AliveCor's new KardiaMobile 6L. I have been a huge advocate of Kardia's single-lead ECG and use it with great success in dozens of my ...
Business Wire

Cardiac Insight’s Cardea SOLO™ ECG System Named as Finalist in Fierce Innovation Awards Healthcare Edition

BELLEVUE, Wash.--(BUSINESS WIRE)--Cardiac Insight, Inc., a leading healthcare innovator specializing in prescription-based wearable cardiac sensors and automated electrocardiogram (ECG) analysis ...
New Atlas

New AI system tracks blood glucose using non-invasive ECG data

For decades one of the holy grails of medical diagnostic devices has been the non-invasive glucose monitor. From wrist-watches to contact lenses, the alluring dream of a device to continually monitor ...
WAVY-TV

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 ...
Healio

Noninvasive ECG mapping system for arrhythmia ‘hot spots’ gains FDA clearance

Please provide your email address to receive an email when new articles are posted on . Vektor Medical announced the FDA has given 510(k) clearance for its novel ECG mapping system, designed to map ...
EDN

-World's First Hospital Quality ECG on a Smartphone Assists Physicians in Early Detection of Potentially Life-Threatening Arrhythmias-

ANN ARBOR, Mich., Nov. 9, 2011 /PRNewswire/ — Everist Genomics, a rapidly growing personalized medicine company developing and commercializing innovative diagnostics and prognostics, today announced ...