Device Dossier

Invasive interstitial-fluid glucose monitoring system

Device Dossier for Invasive interstitial-fluid glucose monitoring system (Invasive interstitial-fluid glucose monitoring system, Class IIb, sponsor…

Intended purpose

The device is a software application for the Dexcom Continuous Glucose Monitoring System and provides users with information to support diabetes management. The Dexcom Continuous Glucose Monitoring System is intended to continuously measure the glucose in the interstitial fluid and is designed to replace fingerstick blood glucose (BG) testing for treatment decisions. The information is displayed via compatible devices.

TGA Public Summary