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 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 ...
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