Business Wire·Nov 13, 2026, 8:30 AM ET

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

The U.S. FDA has cleared the Tandem Mobi system as the world's first & only tubeless automated insulin delivery (AID) device with up to 7 days of wear.
A new tubeless cartridge & infusion set converts existing Tandem Mobi pumps into a tubeless device while retaining Control-IQ+ advanced hybrid closed-loop technology.
The Tandem Mobi is now the only pump offering both tubed & tubeless infusion options, eliminating the need for a new pump for customers with an in-warranty device.
Commercial launch of the tubeless cartridge & infusion set in the United States is scheduled for the first half of 2027.
Products will be available exclusively through pharmacies, with coverage estimated for approximately 50% of insured lives in the U.S. at launch.
The system uses CGM data to predict glucose levels 30 minutes ahead, automatically adjusting insulin & delivering AutoBolus to prevent hyperglycemia.
The device supports multiple wear options, includes a 200-unit cartridge, features inductive charging, & has IP28 water resistance.
Control-IQ+ technology is indicated for Type 1 diabetes patients aged 2+ & Type 2 diabetes patients aged 18+, excluding those with less than 5 units daily insulin needs or under 20 pounds.