Tandem Diabetes has officially secured FDA clearance for its SteadiSet 7-day infusion set, giving pump users a big win in convenience and simplicity. A couple months ago, we reported on the 3-day version receiving clearance, but this latest approval extends wear to a full week—putting Tandem in direct competition with Medtronic, the only other company offering an FDA-cleared 7-day set.
The SteadiSet will be compatible across Tandem’s pump lineup: the t:slim X2, the current tubed Mobi, and the upcoming Tubeless Mobi (expected in 2026). The new tubeless form factor is designed to work seamlessly with both existing and future Mobi units. We’ll have more coverage on the Tubeless Mobi in a YouTube video later this week—stay tuned for that.
The 7-day set introduces three major improvements over today’s infusion sets:
One-handed application: A button-press applicator makes insertion easier for everyone, especially people with dexterity challenges.
Snap-and-twist connection: The tubing clicks into place with a twist, replacing the old pinch-and-pull design.
Advanced cannula design: A coiled cannula reduces kinks, while three insulin exit holes provide backup in case one gets clogged—helping keep insulin delivery consistent over the full wear period.
In a clinical study of 260 participants, about 78% successfully wore SteadiSet for the full seven days. For many users, that could mean cutting infusion set changes nearly in half each week.
Tandem Mobi’s tubeless form factor will incorporate the 7-day infusion set (source: Tandem Diabetes Care).
For people with diabetes, fewer site changes mean fewer disruptions, less skin irritation, and lighter packing when traveling. It’s the kind of behind-the-scenes upgrade that can have a real impact on daily life. And while the SteadiSet will roll out first with Tandem’s tubed pumps, Tandem says it will carry over to the company’s Tubeless Mobi form factor—and I can imaging their upcoming tubeless-first pump in development, Sigi.
The SteadiSet is expected to launch in early 2026. To explore where pump technology is headed, check out our Next-Gen Pumps video. And don’t miss our full Tandem Mobi review, plus new Tubeless Mobi coverage coming later this week on YouTube. What do you think—will a 7-day infusion set change how you manage your diabetes? Share your thoughts in the comments!
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Disclaimer: Diabetech content is not medical advice and is for educational purposes only. Always consult with a physician before making changes to your healthcare.