Tandem Diabetes Care Inc. has announced that its subsidiary, Capillary Biomedical, LLC, has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the SteadiSet Infusion Set. The SteadiSet, designed for adult patients with Type 1 diabetes, is a wearable infusion set that delivers insulin from an insulin pump to the body. It features an integrated inserter with a hidden needle for one-handed insertion and is approved for up to three days of use. Tandem Diabetes Care plans to submit a separate 510(k) application to extend the use period to seven days. Commercial activities for the SteadiSet are expected to commence following the FDA's approval of the extended use period.
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