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 ...

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) ...
Hosted on MSN

HeartBeam (NASDAQ: BEAT) secures FDA 510(k) clearance for 12-lead ECG synthesis software following successful appeal

HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through personalized insights, received FDA 510(k) clearance for its 12-lead ECG synthesis software for ...
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 ...
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 ...
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 ...
PR Newswire

Clario and AliveCor collaborate to offer advanced, trial-focused six-lead ECG solutions for monitoring in decentralized clinical trials

Collaboration brings the next generation of cutting-edge ECG technology to trial participants' homes, enabling accurate cardiac safety trial measurements with fewer site visits. Clario and AliveCor ...
Business Wire

HeartBeam Successfully Meets Clinical Endpoints in Pivotal Study for its Groundbreaking 12-Lead ECG Synthesis Technology

SANTA CLARA, Calif.--(BUSINESS WIRE)--HeartBeam, Inc., (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced ...
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 ...
Morningstar

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

FDA Clearance Granted After Successful Appeal, Overturning Prior Not Substantially Equivalent (NSE) Outcome HeartBeam’s Credit-Card Sized Device Delivers Clinical-Grade Insights Directly to Patients ...
The Globe and Mail

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 ...