HeartBeam Outlines Regulatory Strategy Following FDA Decision on ECG Software

HeartBeam has detailed its regulatory strategy following receipt of a Not Substantially Equivalent decision from the FDA for its 510(k) submission covering its 12-lead ECG Synthesis Software. The company has been in active discussions with FDA review staff, who have signaled willingness to work toward a constructive resolution. HeartBeam stated that its VALID-ECG clinical study met endpoints and that remaining FDA concerns may be resolved through revised labeling.

To advance the regulatory process, the company plans to pursue multiple parallel paths, including a formal appeal or a 510(k) resubmission. HeartBeam believes recent interactions with the FDA indicate a viable path forward under the appeal option, which carries an expected 60-day timeline. The company will continue providing updates on commercialization and funding plans as regulatory engagement progresses.

This regulatory development is significant because HeartBeam's technology represents a potential advancement in cardiac care. 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.

The company's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and HeartBeam holds over 20 issued patents related to technology enablement. The ability to obtain clearance for the ECG Synthesis Software would enable physicians to identify cardiac health trends and acute conditions and direct patients to appropriate care outside of medical facilities, potentially redefining cardiac health management.

Investors and stakeholders can find additional information about the company's developments through its newsroom at https://ibn.fm/BEAT. The regulatory strategy outlined by HeartBeam demonstrates the company's commitment to navigating the FDA process while advancing technology that could transform cardiac care delivery through portable, accessible monitoring solutions.