Dexcom G6® CGM System Receives CE Mark
EDINBURGH, Scotland & SAN DIEGO--(BUSINESS WIRE)--Jun 12, 2018--Dexcom, Inc. (NASDAQ:DXCM), a leader in continuous glucose monitoring (CGM), announced today that the company has received CE Mark for its Dexcom G6 System for people with diabetes ages two years and up.
“The Dexcom G6 represents the future of diabetes management. Not only does the product eliminate the need for fingersticks, but it also maintains the performance, connectivity and accuracy that the diabetes community has come to expect from Dexcom CGM,” said John Lister, Dexcom’s General Manager for EMEA.
The groundbreaking Dexcom G6 will be available in the U.K. and Ireland this month and is expected to be introduced into other European countries later this year. 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. Whether you are a parent of a child with diabetes or an independent adult, the G6 lets you seamlessly keep track of glucose levels and enables the user’s care team to remotely monitor their loved ones for extra peace of mind.
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.”
When available, a new Dexcom patient can order and current users can upgrade to the Dexcom G6 system, which includes a new G6 transmitter and sensors. The new touch screen receiver is optional for international users and can be purchased separately. Users will need a touch screen receiver or compatible smart device and the G6 app, along with the new G6 sensors and transmitter.
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. For more information on Dexcom G6, visit www.dexcom.com/en-GB.
About Dexcom G6
The Dexcom G6 is a stand-alone CGM system for MDI users, which represent the vast majority of the type 1 population, and can also be used by anyone on insulin pump therapy. With the G6, the sensor is worn separately from an insulin pump and is inserted under the skin to measure the level of glucose in the interstitial fluid (fluid in the tissue). The sensor is disposable and should be changed every 10 days.
About DexCom, Inc.
Founded in 1999, Dexcom, Inc. has corporate offices in San Diego, California, EMEA headquarters in Edinburgh, Scotland and users in 39 countries around the world. At Dexcom, we are transforming diabetes care and management by providing superior continuous glucose monitoring (CGM) technology to help people with diabetes and healthcare professionals better manage diabetes. Since our inception, we have focused on better outcomes for people with diabetes, caregivers, and clinicians by delivering solutions that are best in class-while empowering our community to take control of diabetes. For more information on Dexcom CGM, visit www.dexcom.com/global.
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SOURCE: Dexcom, Inc.
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PUB: 06/12/2018 07:00 AM/DISC: 06/12/2018 07:01 AM