HeartBeam Inc. (NASDAQ: BEAT), a medical technology company focused on cardiac monitoring and detection, announced positive results from its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack assessment. The findings, presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2026 conference in San Diego, suggest the company's portable, cable-free electrocardiogram (ECG) technology could improve triage for acute coronary syndrome (ACS) and support remote cardiac assessment.
The study enrolled 132 adults and compared HeartBeam's 3D ECG technology with standard 12-lead ECGs. HeartBeam demonstrated higher specificity than conventional ECGs (81.8% versus 71.4%) and comparable sensitivity (60.2% versus 63.0%). For ST-elevation myocardial infarction (STEMI), sensitivity was 82.9% for HeartBeam compared with 83.8% for standard ECGs. All participants successfully recorded their own ECGs under clinical supervision without prior training, underscoring the device's ease of use. The study also found greater consistency among cardiologists interpreting HeartBeam recordings compared with standard ECGs, supporting the technology's potential for remote cardiac assessment.
These results matter because heart attacks are a leading cause of death, and rapid, accurate diagnosis is critical. Higher specificity means fewer false positives, which could reduce unnecessary hospital admissions and anxiety for patients, while comparable sensitivity indicates the device is effective at detecting true ACS cases. The ability for patients to self-record ECGs without training could enable earlier detection outside of medical facilities, aligning with HeartBeam's goal of delivering actionable heart intelligence wherever the patient is. For a deeper look at the company's technology, see HeartBeam (NASDAQ: BEAT).
HeartBeam plans to use the findings to inform a U.S. pivotal study expected to begin in the first quarter of 2027, with the goal of supporting a future Food and Drug Administration (FDA) submission to expand the system's indication beyond arrhythmia assessment to include heart attack assessment. Although HeartBeam's heart attack assessment technology has received FDA Breakthrough Device Designation, the application remains investigational and is not currently FDA-cleared for heart attack assessment. The full press release is available at https://ibn.fm/8QTjB, and the latest news and updates relating to BEAT can be found at https://ibn.fm/BEAT.
HeartBeam'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. The announcement was distributed through MissionIR, a communications platform that is part of the Dynamic Brand Portfolio at IBN, which provides wire solutions via InvestorWire and other services.
