Tandem Diabetes Care Gets FDA’s 510(k) Clearance for Its Insulin Pump

February 22, 2022

San Diego, Calif.-based Tandem Diabetes Care has received the FDA’s 510(k) clearance for bolus insulin dosing on its t:slim X2 insulin pump using a mobile app.

The t:connect smartphone application can initiate insulin delivery on both iPhone and Android operating systems, giving users the ability to program and cancel bolus insulin requests on their smartphones.

The company said it plans to roll out the mobile bolus feature throughout the spring in a series of limited launches, followed by an expanded launch later this summer.

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