HeartBeam AIMIGo(TM) System

The HeartBeam AIMIGo System is a portable, non-invasive ECG recorder that captures a 3-lead electrocardiogram from 5 electrodes for adults in clinical or home settings. It records, stores, and transmits ECG data to a cloud server for physician review and manual interpretation of non-life-threatening arrhythmias, but does not perform automated cardiac analysis.

The device records 3 channels using 5 dry electrodes with a 30-second duration at 0.5–40 Hz frequency response, powered by a rechargeable lithium-ion battery. It differs from the predicate KardiaMobile 6L (which uses 1–2 channels and 3 dry electrodes) but is similar to the reference device VectraPlex ECG (which supports 3 or 12 channels and 5 or 10 electrodes). Both the subject device and predicate are prescription-use, non-single-use devices for adults.

Software verification per IEC 62304:2006; ECG acquisition and transmission per IEC 60601-2-47:2012; biocompatibility per ISO 10993-1:2018; electromagnetic compatibility and electrical safety per IEC 60601-1:2012, IEC 60601-1-2:2014, and IEC 60601-1-11:2015; usability per IEC 62366-1.

Although the AIMIGo uses 3 channels from 5 electrodes (versus the predicate's 1–2 channels from 3 electrodes), this difference is reconciled by reference to the VectraPlex ECG, which also acquires 3-lead data. The device has identical intended use, patient population, regulatory classification, and prescription-only status as the predicate. Nonclinical bench testing and clinical equivalence studies (pivotal study and device positioning validation) demonstrated that ECG waveforms from the 3-lead AIMIGo are clinically equivalent to standard 12-lead ECG for arrhythmia interpretation. These design and performance differences do not raise new safety or effectiveness questions compared to the predicate.