Dexcom G6 continuous glucose monitor for diabetes receives CE Mark.- Dexcom.

Dexcom, Inc. a leader in continuous glucose monitoring (CGM), announced that the company has received CE Mark for its Dexcom G6 System for people with diabetes ages two years and up. Dexcom G6 encompasses new features that empower users to take control of their diabetes:Elimination of fingersticks for calibration or diabetes treatment decisions. Customisable alarms and alerts to warn users and their designated followers of dangerous glucose levels, even while they are asleep � a particularly useful feature for children and those with impaired hypoglycaemia awareness. An extended 10-day sensor allowing for 43% longer wear than the previous generation Dexcom CGM. A new and smaller transmitter with a 28% lower profile than the previous generation system. An auto-applicator designed to make sensor insertion very simple and as painless as possible with the touch of a button. Continuous glucose readings sent automatically using Bluetooth technology to any compatible smart device, or to a Dexcom receiver, at five-minute intervals. New sensor membrane that enables Paracetamol use without any effect on glucose readings.Furthermore, with the Dexcom G6 app, users can share their glucose information with up to five people.

The CE Marking confirms that the G6 system meets the Essential Requirements of the Medical Device Directive MDD 93/42/EEC as amended by 2007/47/EC. The powerful and ground-breaking new system is also the first CGM system to receive the US Food and Drug Administration�s (FDA) De Novo classification. With this new classification, the Dexcom G6 CGM system is indicated for use as both a stand-alone CGM and for integration into automated insulin dosing (AID) systems.

Comment: Nick Oliver, from the Imperial College London, comments: �For many years, fingerstick blood glucose testing has been a critical component of diabetes self-management. However, the self-monitoring, which can sometimes mean testing blood up to ten or more times a day, can be time-consuming, painful and difficult to fit into a busy day. The Dexcom G6 presents a major advancement for the continuous glucose monitoring category. With Dexcom G6, people with diabetes now have the freedom to live without routine fingersticks and can rely on their CGM data to make treatment decisions, enabling more personalised and effective self-management.�.