HeartBeam Inc. (NASDAQ: BEAT) announced it has completed patient enrollment ahead of schedule in its ALIGN-ACS pilot study, which is evaluating the HeartBeam System for heart attack detection. The study enrolled 120 patients presenting with chest pain at two clinical sites in Belgrade, Serbia. Participants were evaluated using both a standard 12-lead ECG and the company’s 3D ECG technology. Data analysis is currently underway, and HeartBeam plans to present the results at a major cardiology conference later this year.
The company said the study results are expected to support discussions with the U.S. Food and Drug Administration (FDA) on the design of a planned U.S. pivotal trial and a future submission to expand the HeartBeam System’s indication beyond arrhythmia assessment to include heart attack detection. HeartBeam is also evaluating whether completing enrollment ahead of its previously anticipated third-quarter 2026 timeline could support a more accelerated regulatory pathway. This development is significant because it could potentially speed up the availability of a novel, portable heart attack detection technology that may improve patient outcomes by enabling earlier diagnosis and treatment outside of traditional clinical settings.
HeartBeam’s platform technology is designed for portable devices that can be used wherever the patient is, delivering actionable heart intelligence. Physicians would be able to identify cardiac health trends and acute conditions and direct patients to appropriate care, all outside of a medical facility, 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 received clearance in December 2025. HeartBeam holds over 20 issued patents related to technology enablement.
For leaders in business and technology, this news matters because it underscores the rapid advancement of digital health technologies that leverage AI and 3D imaging to create more accessible and effective diagnostic tools. The potential for a cable-free, portable device that can synthesize 3D ECG signals into a standard 12-lead ECG could disrupt the cardiac monitoring market, reducing costs and improving access to care. If successful, the HeartBeam System could become a key tool in telemedicine and remote patient monitoring, areas of growing interest for healthcare investors and technology companies.
The full press release is available at https://ibn.fm/GEYtp. For more information about HeartBeam, including cleared indications for use, visit https://www.heartbeam.com/indications.
