“In the third quarter, we made significant progress with commercial readiness plans in anticipation of FDA clearance for the 12-lead ECG synthesis software submission for arrhythmia assessment,” said Robert Eno, Chief Executive Officer, HeartBeam (BEAT). “We continue to engage in positive and productive discussions with the FDA and our anticipated timeline for this clearance by year end remains intact. Combined with the foundational FDA clearance received in December 2024, this clearance marks a major inflection point for the Company to initiate our commercial launch.”
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