Tandem Diabetes CareDiabetes Care secures FDA clearance for Tandem Mobi insulin pump
12 Jul 2023
Designed to be used as part of an automated insulin delivery system, Tandem Mobi also has Control-IQ technology to predict glucose levels and adjust insulin delivery every five minutes
FDA clears Tandem Mobi insulin delivery system. (Credit: Dennis Klicker on Unsplash)
Diabetes technology company Tandem Diabetes Care has secured clearance from the US Food and Drug Administration (FDA) for its Tandem Mobi insulin delivery system for diabetes patients of age six or more.
Fully controllable from a mobile app, Tandem Mobi is claimed by the company as the world’s smallest durable automated insulin pump.
The system is said to have a 200-unit insulin cartridge and an on-pump button that offers an alternative choice to phone control for bolusing insulin.
Tandem Mobi, which has multiple wear options, is half the size of the t:slim X2 pump, and can fit in a coin pocket, the diabetes technology company said. It can also be attached to clothing or worn on-body with an adhesive sleeve.
According to Tandem Diabetes CareDiabetes Care, the pump is compatible with all existing Tandem-branded and Convatec Group-made infusion sets. The UK-based firm recently developed a new five-inch tubing option for Tandem Mobi.
Tandem Diabetes CareDiabetes Care president and CEO John Sheridan said: “Testing the limits of pump miniaturisation, Tandem Mobi joins the t:slim X2 pump in our family of insulin delivery solutions bringing new options in wearability, the flexibility to disconnect, and full phone control.
“Through this expansion, we are delivering on our commitment to bring greater choice, along with the proven benefits of Tandem’s technology, to more people living with diabetes.”
Designed to be used as part of an automated insulin delivery (AID) system, Tandem Mobi also has Control-IQ technology to predict glucose levels and adjust insulin delivery every five minutes in order to ensure there are no highs and lows.
Control-IQ technology is a hybrid-closed loop algorithm for use by type 1 diabetes patients of age six and more.
Additionally, Tandem Mobi provides full iOS mobile control via the user’s iPhone. It also has inductive charging and can update software remotely and wirelessly via a compatible smartphone.
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