Tandem Diabetes Care (NSDQ:TNDM) said today it won FDA 510(k) clearance for an expanded pediatric indication for its t:slim insulin pump, now indicated for use in children 6 and older.
The San Diego, Calif.-based company said the expanded indication applies to its current t:slim pump features and that there were no changes made to the existing user interface.
“The t:slim Pump has the look and feel of a modern consumer device, which we believe makes it especially well-suited for school-aged children who have grown up in a world of smartphones and tablets. This FDA clearance allows us to share this product with a broader group of children with diabetes and their parents, who we think can benefit greatly from our technology,” CEO Kim Blickenstaff said in a press release.
Last week, Tandem Diabetes said it inked a license agreement with TypeZero Technologies to integrate TypeZero’s artificial pancreas into Tandem’s next-gen t:slim insulin pump.
TypeZero’s artificial pancreas technology includes algorithms developed off of initial research conducted at the University of Virginia, and the company said it has been used in more than 28 clinical studies including more than 475 participants.
Through the deal, Tandem gains worldwide, non-exclusive rights to use the TypeZero AP tech in future Tandem products, and gives Tandem access to future AP innovations over the next 5 years. The companies said they plan to work together to expedite the clinical research associated with the development of Tandem’s closed-loop AP system.
In January, a device developed at the University of Virginia School of Medicine which automatically monitors and regulates blood-sugar level in type 1 diabetes patients began undergoing 2 final clinical trials.
