Results
Tandem Diabetes Care Inc.
08/07/2025 | Press release | Distributed by Public on 08/07/2025 14:11
Material Event (Form 8-K)
Item 8.01 Other Events.
On August 6, 2025, Tandem Diabetes Care, Inc. (the "Company") received 510(k) clearance from the U.S. Food and Drug Administration for the SteadiSet™ infusion set ("SteadiSet") for up to seven days of use. SteadiSet is a wearable infusion set that delivers insulin from an insulin pump to the body and features an integrated inserter with a hidden needle designed for one-handed insertion. SteadiSet is designed to provide patients with type 1 diabetes continuous insulin delivery during the indicated use period.
The Company plans to launch SteadiSet technology as a standalone infusion set for the t:slim X2 and Tandem Mobi pumps and as a component of the Company's future Tandem Mobi tubeless insulin delivery system. The Company will be focusing on the scale-up of manufacturing operations and pre-commercial activities over the next several quarters. Financial details related to these efforts will be provided in future earnings announcements.
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