HeartBeam (NASDAQ: BEAT), a medical technology company developing personalized cardiac-care insights, detailed its strategy following receipt of a Not Substantially Equivalent decision for its 510(k) submission covering its 12-lead ECG Synthesis Software. The Company has been in active discussions with FDA review staff, which have signaled willingness to work toward a constructive resolution. HeartBeam said its VALID-ECG clinical study met endpoints and that remaining FDA concerns may be resolved through revised labeling. To advance the process, the Company plans to pursue multiple parallel paths—including a formal appeal or a 510(k) resubmission—and believes recent interactions indicate a viable path forward under the appeal option, which carries an expected 60-day timeline. HeartBeam will continue providing updates on commercialization and funding plans as regulatory engagement progresses.
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About HeartBeam, Inc.
HeartBeam, Inc. is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company is creating the first-ever cable-free device capable of collecting ECG signals in 3D, from three non-coplanar dimensions, and synthesizing the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management. HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024. The Company holds over 20 issued patents related to technology enablement.
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