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
Tandem Diabetes Care, Inc. (NASDAQ:TNDM), a global insulin delivery and diabetes technology company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Android version of the Tandem Mobi mobile app.
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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 John Sheridan, president and chief executive officer. "This latest integration gives Android users access to the life-changing benefits of Control-IQ+ on a system that emphasizes convenience, discretion, and customization."
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. Jordan Pinsker, chief medical officer.
A limited release is expected to start in December 2025, followed by commercial availability in early 2026. Once available, the Tandem Mobi Android app will be downloadable from the Google Play Store on compatible smartphones, including Google Pixel models 6 through 10 and Samsung Galaxy models S21 through S25. A full compatibility list will be published closer to commercial availability.
To sign up for early access participation, please visit:
https://www.tandemdiabetes.com/TandemMobiAndroid
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. The Company's pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ+ advanced hybrid closed-loop technology. Tandem Diabetes Care is based in San Diego, California. For more information, visit tandemdiabetes.com.
Follow @TandemDiabetesCare on TikTok and @TandemDiabetes on Facebook, Instagram, LinkedIn, and X.
*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 Google Play Store. These statements are subject to numerous risks and uncertainties, including the timing of, and our ability to continue to offer, the Tandem Mobi mobile application on the Google Play Store. These and other risks are identified and described in greater detail under the "Risk Factors" heading of our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other documents filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Actual results could differ materially from those anticipated or projected in the forward-looking statements. Tandem undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events, or other factors.
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.
© 2025 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, the Tandem logo, Control-IQ+, and Tandem Mobi are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. Android and Google Play are trademarks of Google LLC. All third-party marks are the property of their respective owners.
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