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 ...
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 ...
Business Wire

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 ...
Nasdaq

HeartBeam Granted FDA Clearance For First Cable-Free 12-Lead ECG For At-Home Assessment

(RTTNews) - HeartBeam, Inc. (BEAT), a medical technology company, announced Wednesday that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Company's groundbreaking ...
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 ...