Tandem's 7-Day Infusion Set Moves One Step Closer

Tandem Diabetes’ upcoming infusion set is close to making site changes a once-a-week task—and with some serious upgrades.

Its newly upcoming SteadiSet infusion set, developed with Capillary Biomedical (CapBio), just received FDA 510(k) clearance. There are at least two standout design improvements: a one-handed application system and a hidden needle. These user-friendly upgrades address long-desired features for the infusion set experience and are one of the many requested features by pump users.

In 2022, Tandem Diabetes acquired CapBio for an undisclosed amount—bringing the infusion set tech fully in-house. Now, that investment is taking shape with SteadiSet's FDA clearance for three-day wear. But the ultimate goal? Seven days.

While the current FDA clearance is limited to three-day use, Tandem has already confirmed it plans to seek additional 510(k) clearance for up to 7 days of wear. The company is holding off on launching the SteadiSet until this extended use approval is granted—showing confidence in the product's durability and user appeal.

If cleared, SteadiSet would become the second infusion set on the U.S. market with 7-day wear capability.

Currently, only Medtronic’s Extended Infusion Set, used with the MiniMed 780G, offers that level of longevity. Medtronic, for its part, is charging forward with even more innovation—check out my coverage of their upcoming tubeless pump and next-gen 800 series pump. As Tandem positions itself to compete in the 7-day infusion set space, it’s clear the future of diabetes tech is getting smoother, simpler, and more user-centered.

I recently spent three months using the Tandem Mobi, and while the pump has some great features, the current infusion set experience felt clunky. The video below walks through what a site change is like. My full review is coming soon to YouTube, but you can get an early look at how the transition from the tubeless Omnipod to Mobi went in my latest video.

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