Subcutaneous glucose sensor

Intended purpose

The Sensor is a single-patient, single-use component of a personal continuous glucose monitoring (CGM) system. It is intended to communicate via Bluetooth Low Energy (BLE) with a compatible Medtronic insulin pump system to provide glucose information for diabetes management. It calculates glucose concentrations based on collected signals from the interstitial fluid and transmits glucose and device data to the networked device. The sensor is designed to replace fingerstick blood glucose (BG) readings for diabetes treatment decisions. The Sensor is indicated for the management of diabetes in persons ages 2 years and older.