Tandem’s new Mobi automated insulin delivery system has received FDA clearance, making it the world’s smallest insulin delivery system to be fully controllable by a smartphone for ages 2 and older.
Tandem Diabetes Care announced that its forthcoming hybrid closed-loop system, the Tandem Mobi, which had been cleared by the U.S. Food and Drug Administration (FDA) for people ages 6 and up, will now be available to children ages 2 and older with type 1 diabetes.
Both the Tandem Mobi, which comes out in 2024, and Tandem's existing insulin pump, the t:slim X2, utilize Control-IQ Technology, a prescription-only software that automates glucose levels using an algorithm that analyzes continuous glucose monitor (CGM) readings and determines how much insulin to deliver. Control-IQ, which had previously been cleared for ages 6 and above, has now been cleared by the FDA for children 2 years of age and older.