Tandem Mobi Insulin Pump Wins FDA Nod for Android Smartphones

Tandem Diabetes Care has received U.S. Food and Drug Administration (FDA) clearance for the Android version of the Tandem Mobi mobile app.

According to the company, Tandem Mobi is the smallest durable automated insulin delivery (AID) system. It’s powered by Control-IQ+ technology, which Tandem said provides day one improvements, 79% time in range, and 90% overnight time in range.

The Mobi pump received FDA clearance for diabetes patients age six and up in 2023. In 2024, the pump became compatible with the Dexcom G7 continuous glucose monitoring (CGM) system.

“We’re excited to bring Tandem Mobi and the best-in-class outcomes of Control-IQ+ to Android users,” said John Sheridan, Tandem’s president and CEO. “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 mobile app lets users manage their diabetes from a personal, compatible smartphone, which now includes Android devices. The app’s interface and secure connectivity to the Tandem Source platform helps support engagement between patients and healthcare providers, aiming for more informed treatment decisions and better 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, Tandem’s chief medical officer.

Limited release is planned to begin in December 2025, with 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.