Tandem Diabetes Care (NSDQ:TNDM) said today that its t:slim X2 insulin pump won CE Mark clearance in the European Union.
The San Diego, Calif.-based company plans to start selling the device in international markets in the second half of 2018. Tandem’s latest drug-pump won FDA approval in August last year.
The t:slim X2 insulin pump features a rechargeable battery, USB connectivity and a large touchscreen, according to Tandem. The device is also the only pump that can be combined with Dexcom‘s (NSDQ:DXCM) G5 mobile continuous glucose monitor.
The company touted that its insulin pump is 38% smaller than other pumps and can hold 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,” president & CEO Kim Blickenstaff said in prepared remarks.
Tandem shares were off last week after the company topped revenue expectations but missed earnings estimates on Wall Street with its first-quarter results.
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