Tandem Mobi Receives FDA Clearance for Use with Android Smartphones
By adding compatibility with the Android platform, Tandem Mobi is expanding its connected-care ecosystem
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Tandem Mobi Receives FDA Clearance for Use with Android Smartphones
Tandem Mobi, the world’s smallest, durable automated insulin delivery system 1, is powered by Control-IQ+ technology. Proven Control-IQ+ benefits include:
- Day 1 improvements2*
- 79% time in range3†
- 90% overnight time in range4*
“We’re excited to bring Tandem Mobi and the best-in-class outcomes of Control-IQ+ to Android users,” said
The Tandem Mobi mobile app is a secure, user-friendly mobile application designed to seamlessly pair with the Tandem Mobi insulin pump. It enables users to manage their diabetes directly from their personal, compatible smartphone, which will now include Android devices. The app’s intuitive interface and secure connectivity to the Tandem Source platform helps support better engagement between patients and their healthcare providers, facilitating more informed treatment decisions and improved outcomes.
“With the Tandem Mobi mobile app, we’re delivering a solution that meets patients where they are, on the devices they use every day, while maintaining the safety, reliability, and innovation they expect from Tandem,” said Dr.
A limited release is expected to start in
To sign up for early access participation, please visit:
https://www.tandemdiabetes.com/TandemMobiAndroid
About
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*Studies were conducted using a t:slim X2 insulin pump with Control-IQ technology and a Dexcom G6 sensor. † With optimized Correction Factor based on “rule of less than 1600.”
References
-
As of Oct., 2025. Data on file,
Tandem Diabetes Care . - Beck RW, et al. Diabetes Technol Ther. 2023;25(5):329-342.
- Messer LH, Breton M. Diabetes Technol Ther. 2023;25(12):877-882.
- Breton MD, Kovatchev BP. Diabetes Technol Ther. 2021;23(9):601-608.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, the anticipated timing for the availability of the Tandem Mobi Android mobile application as well as our ability to provide the Tandem Mobi Android mobile application on the
Important Safety Information: RX ONLY. The Tandem Mobi insulin pump with interoperable technology (the pump) and Control-IQ+ technology (Control-IQ+) are intended for single patient use. The pump and Control-IQ+ are indicated for use with NovoLog or Humalog U-100 insulin. Tandem Mobi system: The Tandem Mobi insulin pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is indicated for use in persons 2 years of age and greater. Control-IQ+ technology: Control-IQ+ technology is intended for use with compatible integrated continuous glucose monitors (iCGM, sold separately) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.
WARNING: Control-IQ+ technology should not be used in anyone under the age of 2 years old with type 1 diabetes or under the age of 18 years old with type 2 diabetes. It should also not be used in patients who require less than a total daily insulin dose of 5 units of insulin per day or who weigh less than 20 pounds (9 kilograms), as those are the required minimum values needed for Control-IQ+ to operate safely.
Users of the pump and Control-IQ+ must: use the insulin pump, iCGM, and all other system components in accordance with their respective instructions for use. Failure to follow these instructions for use could result in an over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events. Visit tandemdiabetes.com/safetyinfo for additional important safety information.
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