HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care, received U.S. Food and Drug Administration “FDA” Breakthrough Device Designation for the HeartBeam System as a tool for assessing potential heart attacks at home. The designation recognizes the potential of HeartBeam 3D ECG technology to enable physicians to evaluate signs of a possible heart attack when symptoms begin, wherever the patient may be. The FDA granted the designation within 30 days of HeartBeam request, ahead of the agency 60-day statutory review period.
HeartBeam said the designation provides prioritized FDA review and interaction as it advances its heart attack assessment program and is a prerequisite for certain expedited Medicare coverage pathways. The company expects to seek FDA alignment on the design of a multicenter pivotal study in the coming months and anticipates beginning patient enrollment shortly thereafter. If successful, the study is intended to support a future submission to expand the HeartBeam System indications to include heart attack assessment.
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About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) 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 directions, 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 and the 12-lead ECG synthesis software in December 2025(1). The Company holds over 20 issued patents related to technology enablement.
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(1)Cleared Indications for Use
The HeartBeam System with 12-Lead ECG synthesis software for arrhythmia assessment received FDA clearance in December 2025. Refer to the Company’s Cleared Indications for Use at https://www.heartbeam.com/indications for details on the intended use of its technology.
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