BodyGuardian Remote Monitoring System (BGRMS v3.0)

The BodyGuardian Remote Monitoring System (BGRMS v3.0) is a cardiac monitoring system that detects and monitors arrhythmias in ambulatory patients of at least 29 days old in clinical and non-clinical settings. It collects and transmits electrocardiogram (ECG) and other health parameters to healthcare professionals for review and evaluation, but does not provide diagnosis itself.

The system comprises a wearable ECG monitor, mobile app running on off-the-shelf smartphones, server-based PatientCare software with the BeatLogic AI algorithm for ECG analysis, and AI-based device software functionality using deep neural networks for automated classification of continuous ECG data. It supports outpatient cardiac telemetry, cardiac event monitoring, and Holter modalities with communication via Bluetooth, cellular networks, Wi-Fi, and USB.

The system was tested in accordance with ANSI/AAMI EC57 standard for performance measurements including duration and episode measurements relative to ground truth annotations on real-world ECG data.

The proposed device is substantially equivalent to the predicate BodyGuardian Remote Monitoring System (K192732) and secondary predicate SmartCardia 7L (K240653) based on identical intended use for arrhythmia detection and monitoring, same technological architecture (wearable ECG monitors, mobile apps, server software with AI algorithms), same functional modalities, and clinical validation demonstrating substantially equivalent performance for arrhythmia detection across various patient subgroups and device configurations.