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 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 ...
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 ...
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 ...
HeartBeam (BEAT) announced its regulatory strategy following receipt of a Not Substantially Equivalent, or NSE, decision on the company’s 510(k) submission for its 12-lead Electrocardiogram Synthesis ...
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 ...
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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 ...