FDA clears miniature-sized insulin pump for children and adults with diabetes
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Key takeaways:
- The FDA granted clearance for the Tandem Mobi insulin pump for people aged 6 years and older with diabetes.
- The newly approved device is less than half of the size of the Tandem t:slim X2 insulin pump.
The FDA cleared a new, small insulin pump for adults and children ged 6 years and older with diabetes, according to an industry press release.
The Mobi insulin pump (Tandem Diabetes Care) is an automated insulin delivery system that can be fully controlled from a mobile app. The Mobi is less than half of the size of the Tandem t:slim X2 pump, allowing it to fit in a coin pocket, be clipped to clothing or worn on the body with an adhesive sleeve.
“Testing the limits of pump miniaturization, 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,” John Sheridan, president and CEO of Tandem Diabetes Care, said in a press release. “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.”
The Mobi insulin pump features a 200-unit insulin cartridge and is compatible with all existing Tandem-branded infusion sets, including a 5-inch tubing option made for use with Mobi. The pump is compatible with Tandem’s Control-IQ technology and can be fully controlled through use of a mobile app on an iPhone. As an alternative to smartphone control, the device includes an on-pump button for bolusing insulin. The device also features inductive charging and can receive remote software updates through a compatible smartphone, according to the release.
Tandem plans to launch a limited release of the Mobi insulin pump in late 2023, and a full commercial rollout of the device is planned for early 2024, according to the release.
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