HeartBeam Inc. (NASDAQ: BEAT), a medical technology company focused on cardiac care, announced that results from its ALIGN-ACS pilot study will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2026 conference in San Diego. The study evaluated the company’s 3D electrocardiogram (ECG) technology for heart attack assessment. The presentation is scheduled for Nov. 1 at 1:20 p.m. Pacific time and will be delivered by Dr. Graham Nichol of the University of Washington.
The ALIGN-ACS study enrolled 132 emergency department patients presenting with chest pain at two clinical sites in Belgrade, Serbia. It compared the HeartBeam System, a credit card-sized, three-lead device, with a standard 12-lead ECG for detecting acute coronary syndrome. HeartBeam founder and President Branislav Vajdic said the study represents an important step in evaluating the company’s technology against conventional ECG systems in patients with suspected heart attacks.
The news matters because it marks the first clinical comparison of HeartBeam’s portable 3D ECG technology against the standard 12-lead ECG in an emergency setting, where rapid and accurate heart attack assessment is critical. If validated, the technology could enable earlier detection of acute coronary syndrome outside traditional hospital settings, potentially accelerating treatment and improving outcomes. The pilot study findings are expected to help guide the design of a U.S. pivotal study anticipated to begin in the first quarter of 2027, a crucial milestone toward regulatory clearance and broader adoption.
HeartBeam’s technology has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation and has been accepted into the agency’s Total Product Life Cycle Advisory Program. The company’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and for its 12-lead ECG synthesis software in December 2025. For details on the intended use of its technology, refer to the company’s Cleared Indications for Use. HeartBeam holds over 20 issued patents related to technology enablement.
Members of HeartBeam’s management team will also be available for meetings during the TCT conference. The full press release can be viewed at https://ibn.fm/IA88r. The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT.
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