HeartBeam Portable ECG Achieves Up to 92.9% AUC for Heart Attack Risk Prediction
BEAT•A peer-reviewed study shows HeartBeam’s portable ECG device and risk prediction algorithm identified heart attack risk in 184 patients. The model achieved an 86.5% AUC with a single ECG reading plus risk factors and symptoms, rising to 92.9% with a personal baseline ECG, supporting a future heart attack detection indication.
1. Study Design and Results
The proof-of-concept study evaluated 184 patients presenting with chest pain, combining a single portable ECG reading with risk factors and symptoms. The risk prediction algorithm achieved an AUC of 86.5%, rising to 92.9% when compared against a personal, symptom-free baseline ECG reading.
2. Device Technology and Background
HeartBeam’s portable device collects 3D ECG signals from three non-coplanar directions and synthesizes them into a standard 12-lead ECG. The system received FDA clearance for arrhythmia assessment in December 2024 and 12-lead ECG synthesis software clearance in December 2025.
3. Implications for Regulatory Approval and Commercialization
High diagnostic accuracy supports the company’s plans to pursue a dedicated heart attack detection indication for its system. These results advance HeartBeam’s broader clinical program and could accelerate regulatory submissions and market launch.
