The FDA submission is backed by robust data from the VALID-ECG pivotal study, which enrolled 198 patients across five ...
The Company is creating the first ever cable-free synthesized 12-lead ECG capable of capturing the heart’s electrical signals from three distinct directions. This platform technology is designed ...
HeartBeam (NASDAQ: BEAT) , a medical technology company advancing cardiac care, has submitted a 510 (k) application to the U.S. Food and Drug Administration (“FDA”) for its 12-lead electrocardiogram ( ...
including heart attack. Kardia 12L performed comparably to the standard 12-lead ECG in detecting major morphology-related abnormalities. "AliveCor's Kardia 12L ECG System was born from our vision ...
handheld 12-lead ECG system with a unique single-cable design—performs comparably to a standard hospital-grade ECG for detecting common morphological cardiac abnormalities, including heart attack. The ...
HeartBeam has submitted a 510 (k) application to the US Food and Drug Administration (FDA) for its 12-lead electrocardiogram ...
Mitchell did mention that current data on some at-home ECG devices indicates a high likelihood of false positive results, ...
SANTA CLARA, Calif. - HeartBeam, Inc. (NASDAQ: BEAT), a $56.5 million market cap pioneer in medical technology currently trading at $2.12 per share, has announced the submission of a 510(k) ...
Learn more about whether iRhythm Technologies, Inc. or LivaNova PLC is a better investment based on AAII's A+ Investor grades ...
and uses routine 12-lead ECG data to identify left ventricular ejection fraction (LEF), a key indicator of heart failure that is often underdiagnosed. AliveCor chief business officer Sanjay Voleti ...