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 ...
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 ...
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 ...
Nasdaq

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

Anumana Receives First and Only FDA Clearance for ECG-AI Cardiac Amyloidosis Algorithm Using a Standard 12-Lead ECG

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Anumana, Inc., a leader in cardiovascular AI, today announced U.S. Food and Drug Administration (FDA) clearance of its ECG-AI™ algorithm for cardiac amyloidosis (CA) ...