AliveCor, the global leader in AI-powered cardiology, today announced it has received U.S. Food and Drug Administration (FDA) ...
AliveCor announced today that it received FDA clearance for the next generation of its AI technology for the Kardia 12L ECG ...
FDA Clearance Granted After Successful Appeal, Overturning Prior Not Substantially Equivalent (NSE) Outcome HeartBeam’s Credit-Card Sized Device Delivers Clinical-Grade Insights Directly to Patients ...
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 ...
HeartBeam has received FDA clearance for its synthesized 12-lead ECG software, making it the first cable-free device of its kind for at-home arrhythmia assessment. The clearance followed a successful ...
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 ...
HeartBeam Inc. (NASDAQ:BEAT) saw its stock soar 52.6% in premarket trading Wednesday after the company announced that the FDA has granted 510(k) clearance for its 12-lead electrocardiogram (ECG) ...
An investigation has found a "concerning level of variation" in how 12-lead electrocardiogram (ECG) skills are taught in UK undergraduate paramedic programmes. A report by the Health Services Safety ...
(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 ...
HeartBeam, Inc. (BEAT) (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 ...