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The HeartBeam AIMIGo™ System is a portable non-invasive recorder intended to record, store, and transfer a patient's 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional.

The HeartBeam AIMIGo™ System captures a 3-lead (in three-directions) electrocardiogram (ECG) recording of patients who have been prescribed a HeartBeam AIMIGo™ System for recording an ECG remotely. The HeartBeam AIMIGo™ System records and transmits the 3lead ECG signal which can be displayed as rhythm strips on a compatible ECG viewer. The HeartBeam AIMIGo™ System does not provide any analysis of the ECG data nor provide any recommendation toward a clinical diagnosis and is not intended to be used with automated ECG analysis systems. It reports a series of 3-lead ECG rhythm strips for manual interpretation. The hardware platform is designed to be functional and effective with any compatible software designed for the purpose of displaying ECG waveforms for clinical review. The HeartBeam AIMIGoTM System will be provided by prescription only. The system allows the patient (or their caregiver or healthcare provider) the capability to perform the following: - . Record a 3-lead (in three-directions) ECG with the recording device and accompanying mobile Patient Application - Transmit the recorded 3-lead ECG signal to the cloud server, which can then be accessed ● by a clinician via the Clinician Portal for review and manual interpretation. Filters applied may impact the ECG signal morphology, including significant attenuation of lowlevel atrial activity (P-waves / Flutter-waves), which may result in inability to discriminate certain types of arrhythmias (e.g., Atrial Fibrillation/Atrial Flutter). The ECG report produced by HeartBeam AIMIGo is not intended for analysis of the T-wave or other morphological ECG evaluation. The AIMIGo device is not intended for patients with tremors and/or those unable to place and maintain the device in the correct position for the duration of the recording.