AI model detects prediabetes using ECG data without need for blood tests

DiaCardia, a novel artificial intelligence model that can accurately identify individuals with prediabetes using either ...
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.

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 ...
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 ...
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 ...
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 ...
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 ...