Handheld ECG Algorithm Shows Promise for At-Home Heart Attack Risk Assessment

Delays from symptom onset to hospital arrival persist because patients often hesitate to seek care. Tools for reliable at-home risk assessment are limited. A new algorithm integrated with a credit card-sized electrocardiogram device now shows potential to help identify heart attack risk at home.

HeartBeam (Santa Clara, CA, USA) reported peer-reviewed findings in JACC: Advances (June 2026) evaluating a risk prediction algorithm used with the HeartBeam ECG device and the HeartBeam System. The study assessed whether combining device-derived electrocardiogram (ECG) data with patient risk factors and symptom characteristics could identify patients at higher risk of heart attack compared with an expert physician panel. The work aims to strengthen the scientific basis for a potential future indication in heart attack detection.

The approach combines three inputs into a single risk score: an ECG acquired with the handheld, cable-free HeartBeam device, the patient’s pre-existing cardiovascular risk factors, and a structured symptom assessment. HeartBeam’s platform collects ECG signals in three non-coplanar directions and synthesizes them into a 12-lead ECG suitable for portable use. Access to a personal, symptom-free baseline ECG recorded on the same device further improved algorithm performance.

In a prospective cohort of 212 patients presenting to the emergency department with chest pain (184 included in final analysis), the algorithm achieved an area under the curve (AUC) of 86.5% when using one device ECG plus risk factors and symptoms. When a personal, symptom-free baseline ECG was available for comparison, AUC rose to 92.9%. The algorithm’s false-positive rate was 19.8% versus 55.6% for the physician panel (P=0.004), and the authors concluded the integrated approach may enable early-stage acute coronary syndrome risk stratification and help shorten time to treatment.

HeartBeam’s 3D ECG technology received U.S. Food and Drug Administration (FDA) clearance for arrhythmia assessment in December 2024, followed by clearance of its 12-lead ECG synthesis software for the same indication in December 2025. However, the heart attack detection algorithm and indication are not FDA cleared and are currently unavailable in the United States or any other market. HeartBeam cites a U.S. population of more than 20 million patients at risk of heart attack, while this study and the ALIGN-ACS pilot study in Europe, which is enrolling ahead of schedule, advance and broaden the company’s clinical program.

“This study is an important piece of the scientific foundation we are building toward heart attack detection as a future indication for the HeartBeam System,” said Robert Eno, Chief Executive Officer of HeartBeam.

“The results demonstrate that a clinical-grade ECG provided by our device, combined with a patient's clinical history and symptoms, can deliver risk assessment comparable to physician evaluation with a traditional 12-lead ECG. In practical terms, a patient experiencing chest pain could use the HeartBeam System at home, reducing hesitation to seek medical help, reducing time to intervention and potentially improving outcomes in the event of a heart attack,” added Eno.

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