HeartBeam has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for the HeartBeam system as a tool for assessing potential heart attacks at home.
The designation recognises the potential of HeartBeam’s 3D electrocardiogram (ECG) technology—which captures the heart’s electrical signals from three non-coplanar dimensions—to enable physicians to evaluate signs of a possible heart attack, or myocardial infarction (MI), when symptoms start, wherever the patient may be. The US FDA granted the designation within 30 days of HeartBeam’s request—“well ahead” of the agency’s 60-day statutory review period, according to the company.
“One of the biggest gaps in heart attack care today occurs before the patient ever arrives at the hospital. While hospital systems have significantly improved time to treatment inside medical facilities, patients often still delay seeking care because symptoms can be subtle or easily dismissed,” said Tony Das (Baylor Scott & White Health, Dallas, USA), a HeartBeam scientific advisory board member. “HeartBeam’s technology has the potential to address this gap by providing timely access to clinical-grade ECG data outside the hospital, which could enable earlier MI intervention.”
HeartBeam says it is developing its heart attack assessment capability on the same 3D ECG platform behind its US FDA-cleared arrhythmia product, and does not currently anticipate the need for new hardware development.
Obtaining a designation under the US FDA’s Breakthrough Devices Program is set to provide HeartBeam with prioritised FDA review and interaction throughout development, including collaboration on the clinical and regulatory path toward potential clearance.
The Breakthrough Device designation is also a prerequisite for certain expedited Medicare coverage pathways, HeartBeam claims. The US Centers for Medicare & Medicaid Services (CMS) and FDA have proposed the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway, under which the CMS would issue a proposed national coverage determination on the same day an eligible Breakthrough Device receives FDA clearance. HeartBeam has also requested enrolment in the US FDA’s Total Product Life Cycle Advisory Program (TAP).
“Receiving Breakthrough Device designation is an important milestone for our heart attack detection programme,” said Branislav Vajdic, founder and president of HeartBeam. “With heart attack detection now clearly established as HeartBeam’s top strategic priority, the progress across our regulatory, clinical and development programmes points to increasing momentum, and an accelerating path forward. This designation deepens our engagement with the FDA as we work toward alignment on our pivotal study and positions us to pursue an expedited path to Medicare coverage. Both are critical steps toward our goal of giving physicians objective ECG information when heart attack symptoms begin, potentially helping patients seek appropriate care sooner.”
HeartBeam’s Breakthrough Device designation was supported by proof-of-concept data presented at the 2025 American Heart Association (AHA) Scientific Sessions (8–10 November, New Orleans, USA) as well as findings from the 134-patient ALIGN-ACS pilot study. The company expects to seek US FDA alignment on the design of a multicentre pivotal study in the coming months and anticipates beginning patient enrolment shortly thereafter. If successful, the study is intended to support a future submission to expand the HeartBeam system’s indications to include heart attack assessment.
HeartBeam also expects to provide updates in the coming weeks on the ALIGN-ACS data presentation at the 2026 Transcatheter Cardiovascular Therapeutics (TCT) conference (31 October–3 November, San Diego, USA), and the HEADSTART-ACS study.
