HeartBeam Inc. (NASDAQ: BEAT), a medical technology company focused on cardiac monitoring and detection, reported positive results from its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack assessment. The findings were presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2026 conference in San Diego.
The study enrolled 132 adults and compared HeartBeam’s portable, cable-free electrocardiogram (ECG) technology with standard 12-lead ECGs in assessing acute coronary syndrome (ACS). 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. The study also found greater consistency among cardiologists interpreting HeartBeam recordings compared with standard ECGs, supporting the technology’s potential for remote cardiac assessment.
The implications extend beyond incremental improvement. Higher specificity means fewer false positives, which could reduce unnecessary hospital admissions and downstream testing if the technology is validated in larger trials. The ability of patients to self-record ECGs without training suggests the system could enable cardiac assessment outside traditional clinical settings, aligning with broader trends toward decentralized care.
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.
For investors, the pilot data provide a clinical rationale for the planned pivotal trial, though the pathway to FDA clearance remains lengthy and uncertain. The company’s shares trade under the ticker BEAT on Nasdaq, and the latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT. A full press release is available at https://ibn.fm/8QTjB.
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. Details on the intended use of its technology are available in the company’s Cleared Indications for Use at https://www.heartbeam.com/indications.
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