HeartBeam shares surge 25.36% intraday as company announces FDA 60-day appeal and resubmission plans for ECG software.

HeartBeam Inc. surged 25.36% intraday after a pre-market trading session marked by a 43–47% gain, driven by the company’s announcement of a regulatory strategy to address the FDA’s “Not Substantially Equivalent” (NSE) decision on its ECG software. The firm outlined plans for a 60-day appeal and potential 510(k) resubmission, signaling proactive steps to resolve the regulatory hurdle. This followed a prior 58% stock decline post-NSE ruling, as investors reacted to the company’s dual-track approach to expedite clearance. The move reflected optimism about commercial readiness, including partnerships and a 3D ECG system, despite cash flow constraints. The intraday rally aligned with broader market gains, including a 100-point Nasdaq rise, but the primary catalyst was HeartBeam’s strategic response to the FDA decision.