Tandem Mobi Now FDA Cleared as World’s First and Only Tubeless AID System with up to Seven Days of Wear

Tandem Diabetes Care, Inc. (Nasdaq: TNDM), a global insulin delivery and diabetes technology company, today announced U.S. Food and Drug Administration (FDA) clearance of Tandem Mobi for use as the world’s first and only tubeless automated insulin delivery system with up to 7 days of wear.¹ A new Tandem Mobi tubeless cartridge and infusion set converts the current Tandem Mobi pump into a tubeless device that can help simplify diabetes management with less frequent site changes, while offering the life-changing benefits of Control-IQ+ advanced hybrid closed-loop technology. The Tandem Mobi insulin pump is now cleared for tubeless and tubed insulin infusion options, making it the only pump that offers users the flexibility to choose the wear option that best meets their needs.

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“The Tandem Mobi insulin pump was originally designed to make different wear options possible, which now includes a tubeless option with up to 7 days of wear¹,” said John Sheridan, president and chief executive officer. “This clearance of the Tandem Mobi tubeless cartridge and infusion set creates even more possibilities for people living with diabetes, expanding the number of ways to experience the proven benefits of our Control-IQ+ AID technology.”

Full commercial launch of the new tubeless cartridge and infusion set for Tandem Mobi is planned for the first half of 2027 in the United States. Customers with an in-warranty Tandem Mobi will not need a new insulin pump. Existing Tandem Mobi pumps are already compatible and can be used with the new tubeless infusion set and cartridge. Tandem will contact eligible customers with information about how to access the sets and cartridges when they are available.

Tandem Mobi Tubeless infusion sets and cartridges will be available exclusively through the pharmacy for customers with pharmacy benefits. Tandem currently estimates that pharmacy coverage for Tandem Mobi customers is available for approximately 50% of insured lives in the United States, with continued expansion expected ahead of launch and throughout 2027.

To learn more about Tandem Mobi Tubeless, visit https://www.tandemdiabetes.com/TandemMobiTubeless.

About the Tandem Mobi System

Tandem Mobi is the world’s smallest insulin pump that can be worn tubed or tubeless. Powered by Control-IQ+ technology, it uses CGM sensor values to predict glucose levels 30 minutes ahead and automatically adjust insulin as needed, with AutoBolus™ to help prevent hyperglycemia. Tandem Mobi can be used with compatible smartphones via the Tandem Mobi mobile app and supports multiple wear options including tubed and tubeless. Compatible with all Tandem infusion sets, the system allows users to temporarily disconnect for showering, hot tubs, or contact sports. It includes a 200-unit cartridge, inductive charging, water resistance (IP28), remote software updates, and wireless uploads of pump and therapy data to the cloud-based Tandem Source platform.

About Tandem Diabetes Care

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.

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 expected launch timeline and pharmacy availability. These statements are subject to numerous risks and uncertainties, including our ability to market, scale, and maintain the systems, personnel and infrastructure necessary to support the Tandem Mobi Tubeless infusion set and cartridge and the risk that we may encounter other challenges that may delay their availability. 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. Tandem Mobi system: The Tandem Mobi insulin pump with interoperable technology (the 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 intended for single patient, home use and requires a prescription. The pump is indicated for use in individuals 2 years of age and greater. Control-IQ+ technology is intended for use with compatible interoperable continuous glucose monitors (iCGM), 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.

Control-IQ+ technology: Control-IQ+ technology is not a substitute for your own active diabetes management. Control-IQ+ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater. Control-IQ+ technology is intended for use in pregnancy complicated by Type 1 diabetes mellitus, provided the linked CGM system is suitable for use in pregnancy. Control-IQ+ technology is intended for single patient use and requires a prescription.

WARNING: Control-IQ+ technology should not be used in anyone under the age of 2 years old. Control-IQ+ technology should also not be used in patients who require less than a total daily insulin dose of 5 units per day or who weigh less than 20 pounds (9 kilograms), as those are the required minimum values needed in order for Control-IQ+ technology 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.

© 2026 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, Tandem logos, Control-IQ+, AutoBolus, Tandem Mobi, Tandem Source, and t:slim X2 are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. All other third-party marks are the property of their respective owners.

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1		Tubeless infusion set is cleared for up to 7 days of wear. Cartridge is cleared for 3 days of use.

 

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