Tandem Diabetes Care has received FDA clearance for a new tubeless option for its Mobi automated insulin delivery (AID) system. The new tubeless cartridge and infusion set convert the existing Tandem Mobi pump into a tubeless device, allowing users to choose between tubed and tubeless wear. Tandem says Mobi is now the world’s first and only tubeless AID system offering up to seven days of wear.

The new infusion set and cartridge allow users to wear the Tandem Mobi pump directly on their body without traditional tubing. Using an applicator, users attach an infusion site and adhesive patch to their skin. The infusion site is designed to last up to seven days. The updated cartridge holds 200 units of insulin and is designed with a new component (see image below) that allows the Mobi pump to slide directly into place on the adhesive patch. However, while the infusion site can remain in place for up to seven days, Tandem says the new cartridge is only cleared for three days of use and will require more frequent replacement.

Tandem walked us through the infusion site process on the podcast last year, but we were unable to include video of the process because it was not yet cleared. We have reached out to Tandem about coming on the podcast and expect to have them on soon, so stay tuned but subscribing to our YouTube channel or Podcast.

The pump will continue to use Tandem’s Control-IQ+ algorithm. Tandem Mobi will remain compatible with the company’s existing tubed infusion sets, giving users the flexibility to switch between wear options.

A full commercial launch of the tubeless cartridge and infusion set is planned for the first half of 2027 in the United States. Existing Mobi users with an in-warranty pump will not need a new device to use the tubeless option. The new sets and cartridges will be available exclusively through the pharmacy channel, where Tandem currently estimates coverage reaches approximately 50% of insured lives in the U.S.