HeartBeam Inc. (NASDAQ:BEAT) saw its stock soar 52.6% in premarket trading Wednesday after the company announced that the FDA has granted 510(k) clearance for its 12-lead electrocardiogram (ECG) synthesis software designed for arrhythmia evaluation.
The approval comes after HeartBeam successfully appealed a prior FDA decision that classified the technology as Not Substantially Equivalent (NSE). The company’s patented system enables patients to generate clinical-grade ECG readings at home using a compact, credit-card sized device that captures heart signals in three dimensions.
Unlike consumer devices that capture only single-lead or 6-lead data, HeartBeam’s platform produces a synthesized full 12-lead ECG, which is then interpreted by a board-certified cardiologist. This capability allows patients to record heart activity in real time during symptomatic events — something that traditional in-office ECGs often miss.
“This FDA clearance is a defining moment for HeartBeam, and the true beginning of our mission to revolutionize cardiac care,” said Robert Eno, Chief Executive Officer of HeartBeam.
The company plans to roll out the technology in a limited U.S. commercial launch during the first quarter of 2026, focusing on concierge medicine providers and preventive cardiology practices. HeartBeam also intends to pursue regulatory clearance for heart attack detection and is expanding development of an on-demand 12-lead ECG extended-wear monitoring device.
Dr. Robert A. Harrington, a member of the company’s scientific advisory board, emphasized the clinical significance of the platform, explaining that it helps address a longstanding challenge in cardiology by enabling patients to record ECG information precisely when symptoms strike — providing physicians with far more actionable insights.