HeartBeam (NASDAQ: BEAT), a medical technology company focused on cardiac care, announced that results from its ALIGN-ACS pilot study evaluating its 3D electrocardiogram (ECG) technology for heart attack assessment will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2026 conference in San Diego. The presentation, scheduled for Nov. 1 at 1:20 p.m. Pacific time, will be delivered by Dr. Graham Nichol of the University of Washington.
The study enrolled 132 emergency department patients presenting with chest pain at two clinical sites in Belgrade, Serbia, and 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 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. HeartBeam expects the pilot study findings to help guide the design of a U.S. pivotal study anticipated to begin in the first quarter of 2027. Members of the management team will also be available for meetings during the conference.
The significance of the announcement lies in the potential for HeartBeam’s portable 3D ECG technology to transform cardiac care by enabling ECG data collection outside of traditional medical facilities. The HeartBeam System is designed to collect ECG signals in 3D from three non-coplanar directions and synthesize them into a 12-lead ECG, which physicians can use to identify cardiac health trends and acute conditions and direct patients to appropriate care. This could redefine cardiac health management by making actionable heart intelligence available wherever the patient is.
The ALIGN-ACS pilot study is a critical milestone for HeartBeam as it seeks to validate its technology against the standard of care. The results, to be presented at a major cardiovascular conference, will provide valuable data to inform the design of the U.S. pivotal study. 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. HeartBeam holds over 20 issued patents related to technology enablement.
For investors and industry observers, the presentation at TCT 2026 represents a key event that could influence the company’s regulatory pathway and market potential. The full press release can be viewed at https://ibn.fm/IA88r. For more details on the company’s cleared indications for use, refer to https://www.heartbeam.com/indications. The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT.
This news is distributed by AINewsWire, a specialized communications platform focused on AI advancements. AINewsWire is part of the Dynamic Brand Portfolio at IBN, which provides wire solutions via InvestorWire and other services. For more information, visit www.AINewsWire.com.
