Tandem Diabetes Care has secured a new FDA clearance for its insulin dose-calculating algorithm, opening up its use to adults with Type 2 diabetes. The Control-IQ+ program—now with the added ...
The company aims to start a pivotal trial this year, file for 510(k) clearance in 2027 and launch the device in 2028.
Insulet (Nasdaq:PODD) shared new clinical evidence for its first fully closed-loop automated insulin delivery system for type 2 diabetes.
The US Food and Drug Administration (FDA) has expanded the indication for Tandem Diabetes Care’s Control-IQ+ Technology to include people with type 2 diabetes (T2D). The next-generation Control-IQ+ ...
Insulet Presents Promising Study Results for Fully Closed-Loop Automated Insulin Delivery System for Adults with Type 2 ...
52-week follow-up data from type 1 diabetes (“T1D”) patients in COVALENT-112 who completed ≥80% of protocol-specified dosing with the read-out expected in the second quarter of 2026. 26-week primary ...