Tandem Diabetes Care Inc.
11/13/2026 | Press release | Distributed by Public on 11/13/2026 07:35
Material Event (Form 8-K)
Item 8.01 Other Events.
On November 12, 2026, Tandem Diabetes Care, Inc. (the "Company") received 510(k) clearance from the U.S. Food and Drug Administration for Tandem Mobi, 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. 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.
(1) Tubeless infusion set is cleared for up to 7 days of wear. Cartridge is cleared for 3 days of use.
Tandem Diabetes Care Inc. published this content on November 13, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on November 13, 2026 at 13:36 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]