Tandem Diabetes Care (Nasdaq:TNDM) shared in an SEC filing that its Capillary Biomedical (CapBio) subsidiary won FDA 510(k) clearance for a new infusion set.
The company won clearance for its SteadiSet Infusion Set, according to an SEC Form 8-K. It’s a wearable infusion set that delivers insulin from an insulin pump to the body. San Diego-based Tandem itself develops multiple automated insulin delivery systems, including the flagship t:slim X2 and Mobi miniature durable pump. The company could also eventually bring a patch pump system to market.
SteadiSet features an integrated inserter with a hidden needle designed for one-handed insertion. It received clearance to deliver insulin for up to three days of use. According to the FDA’s database, it submitted for clearance in September 2024, and received clearance last week (May 9).
Tandem’s filing says CapBio designed it to provide adult patients with type 1 diabetes with continuous insulin delivery during the indicated use period.
Through CapBio, Tandem also plans to submit a separate 510(k) submission to the FDA to extend the indicated use time to up to seven days. It doesn’t expect to begin commercial activities for SteadiSet until after it receives clearance for the extended use time.
CapBio’s infusion set technology came to Tandem Diabetes Care through a 2022 acquisition for an undisclosed amount. At the time, the company’s “SteadiFlow” infusion set technology — then described as a seven-day set — aimed to significantly extend patient wear time to a week and maintain insulin stability.
The SteadiSet infusion set, powered by the SteadiFlow technology platform, includes an integrated inserter designed for an easy, painless insertion. The entire set includes materials to reduce preservative loss for improved insulin stability and reduced aggregate formation. Capillary Biomedical received FDA investigational device exemption for the platform in January 2022.
