The FDA approved Tandem’s 510(k) application for the use of Mobi in individuals two years of age and older. In an SEC filing dated April 1, the company said the decision came through on March 21.
Previously, Mobi’s indication covered people with diabetes ages six and up. The system’s initial FDA clearance came through in July 2023. Tandem Diabetes Care began the U.S. rollout for Mobi in February.
Mobi, which is fully controllable from a mobile app, is the world’s smallest durable automated insulin delivery (AID) system. It features a 200-unit insulin cartridge and an on-pump button to provide an alternative to phone control for insulin boluses. It comes in at less than half the size of the existing Tandem pump system, the t:slim X2 pump. Mobi can fit in a coin pocket, clip to clothing or go on the body with an adhesive sleeve.
The system features the same Control-IQ technology that powers the established t:slim X2. Control-IQ, an advanced hybrid closed-loop automated insulin delivery feature, predicts and helps prevent high and low blood sugar. It leads to improved time in range throughout the day and night.
More about the Tandem Mobi system
Mobi has compatibility with all existing Tandem-branded infusion sets manufactured by Convatec. That includes a new five-inch tubing option made just for Mobi. Infusion sets allow users to temporarily disconnect from pumps for convenience. The company offers more than 30 mix-and-match infusion site and tubing length combinations.
Additional Mobi features include water resistance to a depth of eight feet for up to two hours. The system has a physical button that allows users to deliver insulin boluses without their iPhone as well. Finally, the system uses modern wireless charging and has remote software update capabilities.
Tandem recently made great strides on its CGM integration, becoming the first to pair an automated insulin delivery to Dexcom’s latest technology when it integrated G7 into the t:slim X2 in December. The company then became the first to add Abbott’s CGM to AID technology by integrating the FreeStyle Libre 2 Plus into the t:slim X2.
According to Tandem, it expects G7 integration for Mobi in the second quarter of this year, followed by the Abbott FreeStyle Libre 3.
