HeartBeam Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care, has received U.S. Food and Drug Administration Breakthrough Device Designation for its HeartBeam System as a tool for assessing potential heart attacks at home. The designation, granted within 30 days of the company's request, ahead of the agency's 60-day statutory review period, recognizes the potential of HeartBeam's 3D ECG technology to enable physicians to evaluate signs of a possible heart attack when symptoms begin, wherever the patient may be. This matters because heart attacks are a leading cause of death worldwide, and timely intervention is critical. By enabling at-home assessment, HeartBeam aims to reduce delays in diagnosis that can lead to irreversible heart damage or death.
The FDA's Breakthrough Device Designation provides prioritized review and interaction as HeartBeam advances its heart attack assessment program. It is also a prerequisite for certain expedited Medicare coverage pathways, which could accelerate patient access and reimbursement if the technology is approved. 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.
HeartBeam's 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. The company's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the 12-lead ECG synthesis software in December 2025. The company holds over 20 issued patents related to technology enablement. For details on the intended use of its technology, refer to the company's Cleared Indications for Use at https://www.heartbeam.com/indications.
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