GlySure Clears European Regulatory Approval For Novel Glucose Monitoring System

The European regulatory approved GlySure Limited’s Continuous Intravascular Glucose Monitoring System (CIGMS). The product will initially be rolled out to leading critical care facilities in the UK, Germany, and the Benelux countries. It is intended for close monitoring of glucose levels in ICU patients. The GlySure CIGMS consists of a disposable central venous catheter, a fiber optic sensor, a monitor that displays the latest glucose reading and a chart covering the last few hours. There’s also an accompanying calibration module.

Before the system is used, a calibration module is used to prepare the sensor. It’s sterile and comes pre-connected to the fully automated sensor.

Once ready, the catheter and sensor is inserted into the patient, the system is activated and the sensor begins taking readings every fifteen seconds, displaying them on the screen.

The company is now working on finalizing a clinical trial that will be used to demonstrate the system’s safety and efficacy to the FDA in order to seek approval in the US.

Source-Medindia