01:06 PM EST, 11/21/2025 (MT Newswires) -- HeartBeam ( BEAT ) shares were down more than 53% in recent trading on Friday after the company reported receiving a "Not Substantially Equivalent" letter from the US Food and Drug Administration regarding the 510(k) application for its 12-Lead Electrocardiogram Synthesis Software.

The company will be working with the agency to resolve the issue, it said in a regulatory filing.

HeartBeam ( BEAT ) said it is also assessing a launch of its novel 3D Electrocardiogram system, which received 510(k) clearance from the FDA in December 2024.

Price: 0.79, Change: -0.90, Percent Change: -53.27