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HeartBeam study shows ECG device may help assess heart attack risk at home

June 2, 2026 7:00 AM

HeartBeam Inc. (NASDAQ: BEAT) announced a peer-reviewed study published in JACC: Advances demonstrating that an algorithm combining its portable ECG device with patient risk factors can identify heart attack risk in patients with chest pain.

The proof-of-concept study, led by Dr. Alexei Shvilkin at Beth Israel Deaconess Medical Center, enrolled 212 patients presenting to emergency departments with chest pain, with 184 included in the final analysis. The research evaluated whether combining ECG data from HeartBeam's credit card-sized device with patient risk factors and symptoms could match physician assessments using traditional 12-lead ECGs.

The algorithm achieved an area under the curve (AUC) of 86.5% when using a single ECG reading from the HeartBeam device combined with patient risk factors and symptoms. When a baseline ECG previously recorded on the same device was available for comparison, the AUC increased to 92.9%.

The study found the algorithm had a false-positive rate of 19.8% compared to 55.6% for the physician panel, indicating fewer patients would be unnecessarily directed to emergency departments.

HeartBeam CEO Robert Eno stated the results demonstrate their device can deliver risk assessment comparable to physician evaluation with traditional ECG equipment. The company views heart attack detection as a potential expansion opportunity, citing a U.S. population of over 20 million high-risk patients.

The HeartBeam System currently has FDA clearance for arrhythmia assessment only. The heart attack detection indication and algorithm are not FDA cleared and not available commercially. The company is conducting the ALIGN-ACS pilot study in Europe as part of its clinical program expansion.

The study was published in the June 2026 issue of JACC: Advances, according to the company's press release.

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