Denmark-based health care company Novo Nordisk has won US FDA 510(k) clearance for the insulin injection device, NovoPen Echo, combining half-unit dosing with a memory function to help patients manage their diabetes.
Available to patients for use with NovoLog (insulin aspart [rDNA origin] injection) PenFill cartridges, the first and only pen device with half-unit dosing and a memory function records the dose and time passed since the last injection.
Novo Nordisk diabetes marketing senior vice president Camille Lee said the US approval of NovoPen Echo represents a significant milestone in insulin delivery, especially for children with diabetes and their caregivers.
"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," Lee added.
Finer adjustments facilitated by half-unit dose increments can be particularly important for children in addition to different removable skins for a kid-friendly customized look.
While NovoPen Echo has already been launched in Europe, Canada, and Israel, the launch in the US is scheduled in early 2014.
