HeartBeam, Inc. (NASDAQ: BEAT) announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to the HeartBeam System for assessing potential heart attacks outside of a hospital setting, according to a company press release.

The designation covers HeartBeam's 3D ECG technology, which captures cardiac electrical signals from three non-coplanar dimensions. The FDA granted the designation within 30 days of HeartBeam's submission, ahead of the agency's 60-day statutory review period.

The FDA's Breakthrough Devices Program is intended to provide patients and clinicians with more timely access to technologies that may offer more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions. The designation provides HeartBeam with prioritized FDA review and interaction throughout development.

Breakthrough Device Designation is also a prerequisite for certain expedited Medicare coverage pathways. The Centers for Medicare and Medicaid Services and the FDA have proposed the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway, under which CMS would issue a proposed national coverage determination on the same day an eligible Breakthrough Device receives FDA clearance. HeartBeam has also requested enrollment in the FDA's Total Product Life Cycle Advisory Program.

The company stated it expects to seek FDA alignment on the design of a multicenter pivotal study in the coming months, with patient enrollment anticipated to begin shortly thereafter. The study, if completed, would be intended to support a future submission to expand the HeartBeam System's cleared indications to include heart attack assessment.

HeartBeam's existing 3D ECG platform previously received FDA clearance for arrhythmia assessment, and the company said it does not anticipate the need for new hardware development for the heart attack assessment application.

The designation was supported by proof-of-concept data presented at the 2025 American Heart Association Scientific Sessions and findings from the 134-patient ALIGN-ACS pilot study. The company expects to provide updates on ALIGN-ACS data at the TCT conference and on the HEADSTART-ACS study in the coming weeks.

HeartBeam estimates the heart attack assessment market opportunity at approximately $15 billion.