Tandem Diabetes Care, a medical device company and manufacturer of touchscreen insulin pumps, has secured 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.
Tandem Diabetes Care 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)2. 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.3
The t:slim X2 Pump is up to 38% smaller than other insulin pumps and holds up to 300 units of insulin.
Tandem Diabetes Care president and CEO Kim Blickenstaff said: “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.
“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."
Tandem Diabetes Care is a medical device company dedicated to improving the lives of people with diabetes through relentless innovation and revolutionary customer experience.
The Company takes an innovative, user-centric approach to the design, development and commercialization of products for people with diabetes who use insulin. Tandem is based in San Diego, California.
Source: Company Press Release