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The FDA clearance unlocks multiple growth initiatives for HeartBeam. The company plans a limited commercial launch in Q1 2026 targeting select concierge and preventive cardiology groups that have ...
Background The 12-lead ECG is a simple, inexpensive clinical tool with a key role in the assessment of patients with hypertrophic cardiomyopathy (HCM). The aims of this single centre, retrospective ...
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 ...
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 ...
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 ...
Abstract: The automatic classification of 12-lead electrocardiogram (ECG) signals plays an important role in diagnosing cardiac abnormalities, providing a faster and more reliable alternative to ...