(RTTNews) - HeartBeam, Inc. (BEAT), a medical technology company, announced Wednesday that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Company's groundbreaking 12-lead electrocardiogram (ECG) synthesis software for the assessment of arrhythmias.
This 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, representing a new level of convenience and peace of mind. The synthesized 12-lead ECG is promptly reviewed by an on-demand, board-certified cardiologist.
With this FDA clearance, the company intends to initiate a limited U.S. commercial launch in the first quarter of 2026. This limited market release will enable the Company to validate real world performance and establish reference sites for broader commercialization.
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