Tandem Mobi Cleared by FDA as the World's First Tubeless Automated Insulin Delivery System, With Infusion Sets Worn Up to Seven Days
Tandem Diabetes Care, Inc. (Nasdaq: TNDM), the San Diego, California-based insulin delivery and diabetes technology company, announced on November 13, 2026, that the U.S. Food and Drug Administration (FDA) has cleared its Tandem Mobi insulin pump for use with a new tubeless cartridge and infusion set, making it the world's first and only tubeless automated insulin delivery (AID) system. A filing with the U.S. Securities and Exchange Commission shows the FDA granted the clearance on November 12.
The new tubeless cartridge and infusion set convert the current Tandem Mobi pump into a tubeless device: the infusion set is cleared for up to seven days of wear and the cartridge for three days of use, meaning less frequent site changes. The pump keeps the Control-IQ+ advanced hybrid closed-loop technology, which uses continuous glucose monitor readings to predict glucose levels 30 minutes ahead and automatically adjust insulin delivery, with AutoBolus to help prevent hyperglycemia. With this clearance, Tandem Mobi is now the only pump cleared for both tubeless and tubed infusion options, letting users choose the wear option that best meets their needs.
“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 wear,” 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 tubeless cartridge and infusion set in the United States is planned for the first half of 2027. Customers with an in-warranty Tandem Mobi will not need a new pump, as existing pumps are already compatible; Tandem will contact eligible customers when the sets and cartridges become available. The tubeless infusion sets and cartridges will be available exclusively through the pharmacy for customers with pharmacy benefits; the company estimates pharmacy coverage is currently available for approximately 50% of insured lives in the United States, with continued expansion expected ahead of launch and throughout 2027.
Tandem Mobi is billed as the world's smallest insulin pump, with a 200-unit cartridge, inductive charging, water resistance (IP28) and smartphone app control, and it can be temporarily disconnected for showering, hot tubs or contact sports. (Source: Tandem Diabetes Care, Inc)
Source: Tandem Diabetes Care, Inc
Published by GSM · USA (original Chinese edition)
Photo: 图：Tandem Diabetes Care 的自动胰岛素输注系统产品图，右侧小泵为 Tandem Mobi，旁置硬币示其体积。图片来源：Tandem Diabetes Care 官网企业官方图。 / Photo: Tandem Diabetes Care automated insulin delivery systems; the small pump at right is Tandem Mobi, shown next to a quarter for scale. Image: Tandem Diabetes Care official product image.
