HeartBeam, Inc.’s (NASDAQ:BEAT) stock is trading higher on Monday, with a session volume of 193.38 million compared to the average volume of 2.191 million as per data from Benzinga Pro.
On Wednesday, the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for HeartBeam’s 12-lead electrocardiogram (ECG) synthesis software for the assessment of arrhythmias.
Arrhythmias are irregular heartbeats where the heart beats too fast (tachycardia), too slow (bradycardia), or with an erratic rhythm.
The clearance follows HeartBeam’s successful appeal of a prior Not Substantially Equivalent (NSE) determination.
Unlike any single-lead or 6-lead consumer device, HeartBeam’s patented cable-free technology captures the heart’s electrical signals in three non-coplanar dimensions and synthesizes them into a 12-lead ECG representation.
This allows patients to obtain an ECG reading for their arrhythmia from the comfort of home, or wherever they happen to be.
The synthesized 12-lead ECG is promptly reviewed by an on-demand, board-certified cardiologist.
The FDA clearance positions the company to advance several growth initiatives:
Limited Launch (Early 2026): The Company plans a targeted rollout to select concierge and preventive cardiology practices that have already expressed strong interest. This controlled introduction will validate real-world performance and establish reference sites ahead of broader commercialization.
Heart Attack Detection Pathway: The Company will pursue an additional indication for heart attack detection, supported by promising proof-of-concept data. Management views this as a major expansion opportunity, potentially reaching tens of millions of U.S. patients.
Extended-Wear 12-Lead Patch: The company is progressing its on-demand 12-lead ECG extended-wear patch, now at the working-prototype stage. The platform targets a multi-billion-dollar reimbursable market and has the potential to offer best-in-class capabilities.
Longitudinal Data and AI: As adoption scales, the company aims to leverage the longitudinal, data-rich output of its 3D ECG technology. Continuous patient-generated 12-lead ECG records could enable AI-driven screening and predictive tools that exceed the capabilities of traditional wearables or single-timepoint ECGs.
The company plans to initiate a limited U.S. commercial launch in the first quarter of 2026 with select concierge and preventive cardiology practices that have already signaled strong adoption interest.
Price Action: BEAT stock is up 75.73% at $1.42 at the last check on Wednesday.
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