A subsidiary of Tandem Diabetes Care (Nasdaq:TNDM) recently picked up FDA clearance for infusion technology to support insulin delivery.
Our sister site, Drug Delivery Business News, reports today that the company 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.
CapBio’s infusion set technology came to Tandem Diabetes Care through a 2022 acquisition for an undisclosed amount.
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.
Get the full story at our sister site, Drug Delivery Business News.
