Tandem Diabetes Gains FDA Approval for Mobi Pump Compatibility with Android Smartphones

Tandem Diabetes Care (NASDAQ:TNDM) announced today that it received FDA approval for the Android version of its Mobi mobile app.
Clearance brings Mobi, the world’s smallest, durable automated insulin delivery system, to more users. The pump, which pairs with Tandem’s Control-IQ+ algorithm, previously worked with iOS software.

Tandem’s Mobi mobile app, a secure, user-friendly mobile application, seamlessly pairs with the Mobi pump. It enables users to manage diabetes directly from their personal, compatible smartphone, now extending to Android devices.

The app features an intuitive user interface and secure connectivity to the Tandem Source platform. This supports better engagement between patients and providers, facilitating more informed treatment decisions and improved outcomes.

San Diego-based Tandem expects to begin a limited rollout next month, followed by full commercial availability in early 2026. Once available, Mobi users can download the Android app from the Google Play Store on compatible smartphones. Those include Google Pixel models 6-10 and Samsung Galaxy models S21-25.

“We’re excited to bring Tandem Mobi and the best-in-class outcomes of Control-IQ+ to Android users,” said John Sheridan, Tandem 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.”

More about the Tandem Mobi system

Tandem launched Mobi in the U.S. last year. It initially received FDA clearance for people with diabetes ages six and up in July 2023. The system then received expanded clearance for pediatric indications last summer. Earlier this year, the pump won CE mark, bringing it to Europe as well.

Mobi features a 200-unit insulin cartridge and an on-pump button to provide an alternative to phone control for insulin boluses. It comes in at less than half the size of the flagship Tandem pump system, the t:slim X2 pump. Mobi can fit in a coin pocket, clip to clothing or go on the body with an adhesive sleeve.

It now utilizes Tandem’s Control-IQ+ technology, an advanced hybrid closed-loop automated insulin delivery feature that predicts and helps prevent high and low blood sugar. Control-IQ leads to improved time in range throughout the day and night. Tandem unveiled the next-generation algorithm earlier this year.

The company built upon its established Control-IQ algorithm to add expanded weight and total daily insulin parameters. It also has enahnced extended bolus capabilities and enabled better meal management. The technology also features an AutoBolus option that calculates and delivers a correction bolus to help with missed meal boluses.

“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 chief medical officer.

For more information about Tandem Diabetes Care please visit www.tandemdiabetes.com.