AliveCor Expands AI-Powered 12-lead Cardiac Diagnostics to Vietnam, Advancing Access to Early Detection and Modernized Cardiac Care

As Vietnam advances national digital health initiatives, connected diagnostic tools are becoming increasingly important. Kardia 12L now strengthens AliveCor's cardiovascular portfolio by standing ...

Anumana Receives First and Only FDA Clearance for ECG-AI Cardiac Amyloidosis Algorithm Using a Standard 12-Lead ECG

Anumana, Inc., a leader in cardiovascular AI, today announced U.S. Food and Drug Administration (FDA) clearance of its ECG-AI (TM) algorithm for cardiac amyloidosis (CA) -- the first and only cleared ...
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 ...
STAT

AliveCor gets FDA nod for portable 12-lead, AI-powered ECG device

AliveCor has spent years battling with Apple over the market for consumer heart monitoring technology. Now it’s hoping to make its imprint on professional health care with its new device, which ...
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 ...
Nasdaq

HeartBeam Receives FDA Clearance for First-Ever, Cable-Free Synthesized 12-Lead ECG for At-Home Arrhythmia Assessment

HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced that the U.S. Food and Drug ...
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 ...
Hosted on MSN

HeartBeam shares skyrocket after FDA signs off on 12-lead ECG synthesis software

HeartBeam Inc. (NASDAQ:BEAT) saw its stock soar 52.6% in premarket trading Wednesday after the company announced that the FDA has granted 510(k) clearance for its 12-lead electrocardiogram (ECG) ...
Nasdaq

BEAT Secures FDA Nod for First Cable-Free At-Home 12-Lead ECG System

HeartBeam BEAT recently secured FDA 510(k) clearance for its first-of-its-kind, cable-free synthesized 12-lead ECG technology, marking a major inflection point in the company’s mission to modernize ...