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) ...
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 ...
Becker's Hospital Review

1st synthesized 12-lead ECG to launch in 2026

HeartBeam has received FDA clearance for its synthesized 12-lead ECG software, making it the first cable-free device of its kind for at-home arrhythmia assessment. The clearance followed a successful ...
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 ...
Morningstar

HeartBeam Provides Update on Regulatory Path Following FDA Decision on 12-Lead ECG Synthesis Software Application

Company engaging in multiple options for a constructive resolution Strategy is underpinned by a clinical study that achieved the agreed upon endpoints Company believes that labeling modifications can ...
Business Wire

First Patients Enrolled in Pivotal Study Evaluating HeartBeam’s AIMIGo™ System for Synthesizing a 12-Lead ECG

SANTA CLARA, Calif.--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, announced today that ...
Hosted on MSN

HeartBeam (NASDAQ: BEAT) ranks second worldwide in 12-lead ECG innovation

HeartBeam (NASDAQ: BEAT), a medical-technology company developing advanced electrocardiogram solutions, was featured in a recent article that discussed its recognition as a Global IP and Technology ...
MD&M East

HeartBeam’s Algorithm Synthesizes a 12-Lead ECG Output in a Credit-Card-Sized Device

Twelve-lead ECGs, although standard in hospitals, can be bulky and impractical for home use. On the other hand, Apple Watch’s ECG app is easy to use, but it is limited in what it can detect because it ...
Business Wire

HeartBeam Granted Patent for 12-Lead Electrocardiogram (ECG) Patch Monitor Intended for Detection of Heart Attacks and Complex Cardiac Arrhythmias

SANTA CLARA, Calif.--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D-vector ECG platform for heart attack detection anytime, ...