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Tandem has announced plans to submit its tubeless Tandem Mobi to the FDA this quarter, with clearance expected in the second half of 2026. This would be Tandem's first tubeless insulin pump, and the first-ever tubeless/tubed hybrid pump, putting it in direct competition with Insulet's Omnipod 5 patch pump.

The tubeless Tandem Mobi is an upcoming add-on for the existing Mobi insulin pump that allows users to wear the pump directly on the body without tubing. It uses a new infusion set and insulin cartridge that converts the Mobi into a tubeless system, giving users the flexibility to switch between tubed and tubeless wear.

Following FDA clearance, Tandem plans a phased commercialization approach, initially rolling out the product to small groups to evaluate real-world performance before a full launch. Back in September, Tandem gave us a closer look at the tubeless Tandem Mobi and how it functions. Tandem isn't alone in this space, as other companies are also working on tubeless insulin pumps, with Beta Bionics developing the Mint and Medtronic working on the Sigi. Exciting times ahead for users who opt for a tubeless insulin pump.

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