Tandem Wins FDA Clearance On First Stand-Alone Glycemic Controller

Tandem Diabetes Care received FDA clearance for its Control-IQ technology for use with Tandem's t:slim X2 insulin pump and Dexcom's G6 continuous glucose monitoring system, making it the first hybrid closed-loop system to deliver automatic correction boluses and adjust background insulin levels to help prevent high and low blood sugars.

An automated insulin delivery system that landed marketing authorization from the US Food and Drug Administration on 13 December represents a breakthrough for patients with type 1 diabetes.

Tandem Diabetes Care Inc.'s Control IQ is an automated insulin delivery system that combines the t:slim X2 insulin pump,...