HeartBeam has secured US Food and Drug Administration (FDA) clearance for its 12-lead electrocardiogram (ECG) synthesis software, setting the arrhythmia assessment tool up for deployment in patients’ homes.
The company’s ECG system comes in the form of a credit card-sized device that patients hold to their chest to record the heart’s electrical signals. Known as vector electrocardiography (VECG), HeartBeam’s technology works by gathering 3D signals of the heart and converting them into a 12-lead ECG.
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Via a companion smartphone app, once ECG recordings are captured, they get uploaded to HeartBeam’s cloud and are interpreted by ‘on-call’ cardiologists who then follow up with a patient.
FDA clearance for the device was supported by data from HeartBeam’s VALID-ECG pivotal study (NCT06123130). The study measured the mean difference in ECG intervals and amplitude between the company’s ECG software and standard 12-lead ECG.
The study met its primary endpoints, finding that the software held a 93.4% diagnostic agreement, suggesting HeartBeam’s system to be comparable to traditional 12-lead ECG readings as a means of diagnosing heart arrhythmias.
HeartBeam plans to initiate a limited US market launch of its software to select preventative cardiology practices from Q1 2026.
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By GlobalDataArrhythmias refer to abnormal heart rhythms. To continue advancing its software development, HeartBeam said it plans to pursue a heart attack detection indication for its software in future.
HeartBeam CEO Robert Eno said: “We look forward to initiating our US market introduction while advancing our efforts on heart attack detection, an on-demand 12-lead extended wear patch, and AI-based screening and prediction algorithms trained on our unique longitudinal data.”
HeartBeam’s approval with the FDA was concluded following an initial stumbling block wherein the agency issued a Not Substantially Equivalent (NSE) decision over the company’s software. On appeal, the initial ruling was overturned. NSE is a designation usually imposed by the FDA when a device is considered not to be ‘similar enough’ to a legally marketed ‘predicate’ device.
