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 ...
TMCnet

Anumana Secures FDA Clearance for First-of-Its-Kind ECG-AI Algorithm for Early Detection of Pulmonary Hypertension

PH is a progressive, life-threatening pulmonary vascular disease estimated to affect up to 1% of the global population. 1 It is often difficult to diagnose 2 due to non-specific early symptoms, such ...
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 ...

FDA approves Anumana’s pulmonary hypertension algorithm

The algorithm integrates with EHR systems and ECG platforms, operating within the health system without external data ...
Nasdaq

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 ...
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 ...
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 ...