Global insulin delivery and diabetes technology company Tandem Diabetes Care, Inc. (NASDAQ:TNDM) secured U.S. Food and Drug Administration clearance for Tandem Mobi as the world’s first and only tubeless automated insulin delivery system offering up to seven days of wear for users.
The FDA clearance covers a new tubeless cartridge and infusion set that converts the current Tandem Mobi pump into a tubeless device.
Tandem says the new components can simplify diabetes management through less frequent site changes while supporting Control-IQ+ advanced hybrid closed-loop technology.
The company says Mobi is now the only insulin pump cleared for both tubed and tubeless wear options.
Tubed or Tubeless Flexibility With Automated Insulin Delivery
Tandem describes Mobi as the world’s smallest insulin pump that can be worn tubed or tubeless.
Control-IQ+ technology uses continuous glucose monitor (CGM) readings to predict glucose levels 30 minutes ahead and automatically adjust insulin delivery, with AutoBolus to help prevent hyperglycemia.
Patients operate the pump through compatible smartphones using the Tandem Mobi mobile app.
The system works with all Tandem infusion sets and allows users to temporarily disconnect for showering, hot tubs or contact sports.
The pump includes a 200-unit cartridge, inductive charging and an IP28 water-resistance rating.
It also supports remote software updates and wirelessly uploads pump and therapy data to the cloud-based Tandem Source platform.
2027 US Commercial Launch and Pharmacy Coverage
Tandem plans to launch the new tubeless cartridge and infusion set commercially across the U.S. in the first half of 2027.
Customers with an in-warranty Tandem Mobi will not need a new pump because existing pumps are compatible with the new tubeless components.
Tandem will contact eligible customers with details on how to access the new sets and cartridges when they become available.
Pharmacies will exclusively supply Tandem Mobi Tubeless infusion sets and cartridges to patients with pharmacy benefits.
Tandem estimates that pharmacy coverage for Mobi is available to roughly 50% of insured lives in the U.S. and expects coverage to expand ahead of the launch and throughout 2027.
TNDM Price Action: Tandem Diabetes Care shares were up 14.48% at $20.05 at last check Friday, according to Benzinga Pro data.
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