Tandem Diabetes Care Inc. Receives FDA Clearance for SteadiSet Infusion Set for Up to Three Days of Use

Reuters
13 May
<a href="https://laohu8.com/S/TNDM">Tandem Diabetes</a> Care Inc. Receives FDA Clearance for SteadiSet Infusion Set for Up to Three Days of Use

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Tandem Diabetes Care Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001438133-25-000072), on May 12, 2025, and is solely responsible for the information contained therein.

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