Tandem wins CE mark for automated insulin delivery in type 2 diabetes, pregnancy

Tandem Diabetes Care (Nasdaq:TNDM) announced today that it received expanded CE mark for its automated insulin delivery (AID) systems.

San Diego-based Tandem can now bring its Control-IQ-powered AID systems — the flagship t:slim X2 and miniature Mobi — to European adults with type 2 diabetes and those with type 1 diabetes during pregnancy. Approval in Europe follows FDA nods for type 2 in early 2025 and for pregnancy just over a month ago.

Tandem supported its type 2 label expansion with strong clinical evidence from its 2IQP trial of more than 300 people. The study compared t:slim X2 with Control-IQ+ to a control group continuing multiple daily injections (MDI).

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