HeartBeam Accelerates Heart Attack Detection Study Completion
Event summary
- HeartBeam completed enrollment in its ALIGN-ACS pilot study ahead of schedule, originally targeted for Q3 2026.
- The study enrolled 120 patients across two clinical sites in Belgrade, Serbia, evaluating the HeartBeam System against standard 12-lead ECGs.
- Results are expected to inform FDA discussions for an expanded indication beyond arrhythmia assessment to include heart attack detection.
- HeartBeam aims to present findings at a major cardiology conference later this year.
The big picture
HeartBeam's early completion of the ALIGN-ACS study underscores its push to expand beyond arrhythmia assessment into heart attack detection, a critical area with high mortality rates. The company is positioning itself at the forefront of portable cardiac diagnostics, aiming to reduce delays in care through technology that enables earlier intervention. Success here could redefine how acute coronary syndrome is managed outside traditional clinical settings.
What we're watching
- Regulatory Pathway
- Whether the ALIGN-ACS data will support an accelerated FDA submission for heart attack detection.
- Clinical Validation
- The pace at which HeartBeam can transition from pilot to pivotal study based on current results.
- Market Expansion
- How quickly HeartBeam can scale its 3D ECG technology if cleared for broader cardiac indications.
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