HeartBeam device shows higher specificity than standard ECG in heart attack pilot study
BEAT•HeartBeam reported positive results from its 132-patient ALIGN-ACS pilot study: patient-recorded ECGs produced fewer false positives than standard 12-lead ECGs while showing comparable ability to detect acute coronary syndrome.
1. Pilot study findings
HeartBeam said results from its 132-patient ALIGN-ACS pilot study were presented at the TCT 2026 conference in San Diego. Patient-recorded ECGs produced fewer false positives than standard 12-lead ECGs, with comparable ability to detect acute coronary syndrome, and cardiologists interpreted the device recordings more consistently.
2. Next study planned
All patients successfully recorded their own ECGs under clinical supervision without prior training. The findings will inform a U.S. pivotal study planned for the first quarter of 2027 to support an expanded FDA indication. The system is not currently FDA-cleared for heart attack assessment, which remains investigational.
