HeartBeam shares surge 37.49% premarket as FDA regulatory strategy outlined after Not Substantially Equivalent decision.

HeartBeam surged 37.49% in premarket trading following an after-hours announcement where the company outlined its regulatory strategy in response to the FDA's Not Substantially Equivalent determination. The disclosure, which came after a 40.75% after-hours jump, indicated the firm is addressing the agency’s concerns, signaling progress toward regulatory alignment and renewed investor confidence in its approval pathway.