Why Did BEAT Stock Rocket 72% In Pre-Market Today?

• The clearance enables HeartBeam’s cable-free technology to capture the heart’s electrical signals in three dimensions.
• The approval follows a successful appeal of a prior Not Substantially Equivalent (NSE) determination.
• The company intends to roll out a controlled commercial launch in early 2026.

HeartBeam, Inc. (BEAT) on Wednesday announced that the U.S. Food and Drug Administration (FDA) has cleared its 12-lead electrocardiogram (ECG) synthesis software for arrhythmia assessment, which enables its cable-free technology to capture the heart’s electrical signals in three dimensions and convert them into a complete 12-lead ECG.

The approval follows a successful appeal of a prior Not Substantially Equivalent (NSE) determination, marking a significant milestone for the company.

Why It Matters?

Unlike traditional single-lead or 6-lead devices, this innovation allows patients to obtain accurate cardiac readings from home, with synthesized results promptly reviewed by board-certified cardiologists.

Following the announcement, HeartBeam’s stock traded over 72% higher in Wednesday’s premarket. On Stocktwits, retail sentiment around the stock jumped to ‘extremely bullish’ from ‘bearish’ territory the previous day, while message volume shifted to ‘high’ from ‘low’ levels in 24 hours. 

“We look forward to initiating our U.S. market introduction while advancing our efforts on heart attack detection, an on-demand 12-lead extended wear patch, and AI-based screening and prediction algorithms trained on our unique longitudinal data.”

-Robert Eno, CEO, HeartBeam

Limited U.S. Launch Planned

The company intends to roll out a controlled commercial launch in early 2026, targeting select concierge and preventive cardiology groups that have expressed strong interest. 

It has developed a working prototype of an extended-wear 12-lead ECG patch, designed to provide continuous cardiac monitoring. As HeartBeam’s 3D ECG platform adoption grows, the resulting data repository will enable longitudinal analysis. The company plans to use this data to develop AI-based screening and predictive algorithms.

BEAT stock has lost over 64% in 2025 and over 73% in the last 12 months. 

Also See: Lucid Signals Tough Road Ahead Amid Slumping EV Demand: CEO Says ‘There Is A Slowdown, There’s No Question About It’

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