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 ...
Yahoo Finance

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 ...
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 ...
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 ...
Business Wire

HeartBeam Achieves Major Milestone with FDA Submission for its Groundbreaking 12-Lead ECG Synthesis Software

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 it ...
Investing

HeartBeam’s 12-lead ECG synthesis software receives FDA clearance

The company notes the synthesized output is not intended to replace a standard 12-lead ECG. HeartBeam also plans to advance development of an on-demand 12-lead ECG extended wear monitor and build ...
Seeking Alpha

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

HeartBeam, Inc. (BEAT) (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 ...