FDA Clearance for NovoPen Echo

Novo Nordisk officials announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the insulin device NovoPen Echo. This marks the first and only pen device in the U.S. with half-unit dosing and a memory function that records the dose and time passed since the last injection.

This pen is the latest insulin delivery system from Novo Nordisk, and will be available to patients for use with NovoLog (insulin aspart [rDNA origin] injection) PenFill cartridges. 

"The U.S. approval of NovoPen Echo represents a significant milestone in insulin delivery, especially for children with diabetes and their caregivers," states Camille Lee, senior vice president, Diabetes Marketing at Novo Nordisk. "The pen can offer caregivers increased confidence that their children are managing their diabetes appropriately away from home by allowing them to see the amount and time passed since their last dose." 

Half-unit dose increments allow for finer adjustments, which can be particularly important for children. In addition, different removable skins will be available for a kid-friendly customized look.

Novo Nordisk plans to make NovoPen Echo available in the U.S. in early 2014. NovoPen Echo has already launched in Europe, Canada, and Israel.