HeartBeam shares surge 54.48% premarket after announcing 60-day FDA appeal and resubmission plans for ECG software.

HeartBeam Inc. (NASDAQ: BEAT) surged 54.48% in premarket trading following its announcement of a regulatory strategy to appeal the FDA’s "Not Substantially Equivalent" (NSE) decision on its 12-lead ECG synthesis software and pursue a 510(k) resubmission. The company outlined plans for a 60-day appeal process and adjustments to address FDA concerns, signaling a dual approach to expedite regulatory clearance. This proactive stance, despite cash constraints and prior volatility from the NSE ruling, reignited investor optimism about potential 2026 commercialization. The move aligns with recent news emphasizing Heartbeam’s efforts to navigate the NSE outcome while maintaining commercial readiness through partnerships and existing cleared products.