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HeartBeam (NASDAQ: BEAT) secures FDA 510(k) clearance for 12-lead ECG synthesis software following successful appeal

HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through personalized insights, received FDA 510(k) clearance for its 12-lead ECG synthesis software for ...
Investing

HeartBeam receives FDA NSE letter for ECG software, evaluates 3D ECG system launch

HeartBeam, Inc. (NASDAQ:BEAT) announced Thursday that it received a Not Substantially Equivalent (NSE) letter from the U.S. Food and Drug Administration regarding its 510(k) application for its ...
Investing

HeartBeam pursues multiple options after FDA rejection of ECG software

SANTA CLARA - HeartBeam, Inc. (NASDAQ:BEAT) is pursuing multiple regulatory paths after receiving a Not Substantially Equivalent (NSE) decision from the Food and Drug Administration (FDA) for its ...