The regulatory win makes the device the first sensor-augmented insulin pump cleared to let users make treatment decisions without pricking their finger, the company touted.
The San Diego, Calif.-based company said that the software used with this pump will be available to current t:slim X2 pump users at no additional cost, enabling them to add CGM-integration to their existing pumps.
“We are setting a new standard in our industry by simultaneously offering our existing and future customers the benefits of best-in-class CGM integration on our simple-to-use touchscreen insulin pump,” Tandem’s president & CEO Kim Blickenstaff said in prepared remarks. “The t:slim X2 Pump is designed to accelerate the pace in which we can bring new innovations to people with diabetes, which is of particular importance as we develop software updates to add automated insulin delivery algorithms to our platform.”
The t:slim X2 device can be paired with Dexcom’s CGM or it can operate as a stand-alone insulin pump.
“Dexcom has been moving its technology forward at a rapid pace, and Tandem’s ability to roll out remote software updates like this opens up exciting possibilities for faster integrations of our future products,” Steve Pacelli, Dexcom’s EVP of strategy & corporate development, added. “We are excited to have our latest CGM technology integrated with their t:slim X2 Insulin Pump, and to see it offered not only to new customers but also to existing t:slim X2 Pump users.”