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HeartBeam ALIGN-ACS Pilot Study: Key FAQs
HeartBeam completed patient enrollment ahead of schedule in its ALIGN-ACS pilot study for heart attack detection using its 3D ECG technology, with results expected to support FDA discussions and potentially accelerate regulatory approval.
It is a study evaluating HeartBeam's system for detecting heart attacks, enrolling 120 patients with chest pain at two clinical sites in Belgrade, Serbia.
Results will support FDA discussions for a U.S. pivotal trial and a future submission to expand HeartBeam’s indication to include heart attack detection, potentially accelerating regulatory approval.
It uses a cable-free device that collects 3D ECG signals from three non-coplanar directions and synthesizes them into a standard 12-lead ECG.
The study is conducted by HeartBeam at two clinical sites in Belgrade, Serbia.
Enrollment completed ahead of schedule, and results are planned to be presented at a major cardiology conference later this year.
HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and for 12-lead ECG synthesis software in December 2025.
The study compares HeartBeam’s 3D ECG technology to the standard 12-lead ECG for heart attack detection.
Success could lead to expanded FDA indication for heart attack detection and enable use outside medical facilities, redefining cardiac health management.
Visit HeartBeam's newsroom at https://ibn.fm/BEAT or the full press release at https://ibn.fm/GEYtp.