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.
Now, the company has that clearance for the seven-day set. According to the database, it submitted for a 510(k) on June 17 and received the clearance on Aug. 6.
Read more about Tandem and the rest of the diabetes tech industry in our free Diabetes Technology Special Report.
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. Tandem/CapBio designed the set to provide adult patients with type 1 diabetes with continuous insulin delivery during the indicated use period.
“Essentially, these AID systems and the pumps are just amazing at providing benefits,” Mar said in Chicago in June. “But infusion sets, overall, if you’re not getting the insulin reliably in your body, then the benefits of these really aren’t there. We’re really excited to make some meaningful developments on the infusion set side.”
