HeartBeam Provides Update on Regulatory Path Following FDA Decision on 12-Lead ECG Synthesis Software Application

HeartBeam Provides Update on Regulatory Path Following FDA Decision on 12-Lead ECG Synthesis Software Application ...
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 ...
TipRanks on MSN

HeartBeam updates regulatory strategy for 12-lead ECG Synthesis Software

HeartBeam (BEAT) announced its regulatory strategy following receipt of a Not Substantially Equivalent, or NSE, decision on the company’s 510(k) ...

Heartbeam Inc. (NASDAQ: BEAT) Recognized As A Top Global Innovator In Portable ECG Technology

Recognized As A Top Global Innovator In Portable ECG Technology. <li /> The company was ranked second worldwide out of 243 companies evaluated in 12-lead ECG innovation in PatentVest's“Total Cardiac ...
Business Wire

HeartBeam’s Deep Learning Algorithms Demonstrate High Rates of Accuracy for Detecting Arrhythmias

New study presented at HRX Live 2025 demonstrates continued advancement of company’s AI program HeartBeam's AI algorithm performed equally well on HeartBeam 3D ECG system and standard 12L ECGs in ...
TipRanks on MSN

Roth sees potential FDA clearance for HeartBeam despite letter

Roth Capital keeps a Buy rating on HeartBeam (BEAT) with a $4 price target after the company received a “not substantially equivalent” letter from ...
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 ...
Medscape

ECG Challenge: Worsening Episodes of Chest Pain

A 52-year-old man hospitalized with chest pain is found to have a slow heart rate and evidence of heart block. What does an ...
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 ...