Tandem Diabetes Care (Nasdaq:TNDM) has a new infusion set on the way to pair with its insulin delivery offerings.
Our sister site, Drug Delivery Business News, reports today that the FDA’s 510(k) database indicates that Tandem recently received clearance for an extended-wear infusion set.
Tandem’s Capillary Biomedical (CapBio) subsidiary develops the SteadiSet Infusion Set. The wearable infusion set delivers insulin from an insulin pump to the body. Tandem — one of the largest diabetes tech companies in the world — develops the t:slim X2 and Mobi insulin pump systems to work with the infusion set.
Initially, SteadiSet received FDA clearance in May. However, through CapBio, Tandem said it planned to submit a separate 510(k) submission to the FDA to extend the indicated use time to up to seven days. It didn’t expect to begin commercial activities for SteadiSet until after it receives clearance for the extended use time.
Get the full story at our sister site, Drug Delivery Business News.
