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Tandem Diabetes Care®, Inc., a medical device company and manufacturer of the only touchscreen insulin pumps, announced receipt of CE mark approval for the t:slim X2™ Insulin Pump with Dexcom G5® Mobile continuous glucose monitoring (CGM) integration. The Company plans to begin commercial sales of the pump in select international markets beginning in the second half of 2018. The Company has been commercializing its touchscreen insulin pumps in the United States since 2012, and received U.S. Food and Drug Administration (FDA) approval of the t:slim X2™ Insulin Pump with Dexcom G5 Mobile CGM integration in August 2017.
The simple-to-use t:slim X2 Insulin Pump includes advanced features like a large color touchscreen, rechargeable battery, USB connectivity and watertight construction (IPX7). It is the only pump that integrates with Dexcom G5 Mobile CGM, and the first CGM-enabled pump approved to let users make treatment decisions without pricking their finger. The t:slim X2 Pump is up to 38% smaller than other insulin pumps and holds up to 300 units of insulin.
“As our first product to receive CE mark, this milestone is key to the fulfillment of our vision to bring the features and benefits of our unique insulin pump technology to people outside of the United States,” said Kim Blickenstaff, President and CEO of Tandem Diabetes Care. “Our plans to launch the t:slim X2 Pump internationally in the second half of this year is of particular strategic importance during this time where insulin pump options are becoming increasingly limited.”
For Further Information
More on the diabetes device market in Europe can be found in a series of reports published by iData Research entitled the Europe Market Report Suite for Diabetes Devices . The suite covers reports on the following markets: blood glucose meters, blood glucose test strips, lancets and lancing devices, continuous glucose monitoring (CGM), insulin, insulin pens, insulin syringes and insulin pumps.
The iData report series on diabetes devices covers the US and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about diabetes device market data or procedure data, register online or email us at [email protected] for a Europe Market Report Suite for Diabetes Devices brochure and synopsis.