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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 ...
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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 ...