Novo Nordisk landed FDA 510(k) for its NovoPen Echo, which the company touts as the 1st insulin pen to combine half-unit dosing with a memory log to help patients keep track of injection dose and time.
The Plainsboro, N.J.-based medical device maker said its new pen will be on the shelves in 2014. The FDA clearance follows green-lights from regulators in Canada, Europe and Israel.
The newly cleared pen is only for patients already using the company’s NovoLog cartridges, which use a synthetic insulin for diabetic adults and children to control their high blood sugar.
"The U.S. approval of NovoPen Echo represents a significant milestone in insulin delivery, especially for children with diabetes and their caregivers," Camille Lee, senior VP of diabetes marketing, said in prepared remarks. "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."
The pen also allows patients to use more finely tuned doses by adjusting to half-units rather than full units alone, which the company notes can be particularly important for children. To top it off, the pens are customizable with "kid-friendly" skins, including leopard skin prints, ladybugs, frogs and soccer balls.