EU clears disposable insulin delivery device
Valeritas has received European CE mark approval for a disposable insulin delivery device designed to provide basal-bolus therapy for adults who require insulin injections. The Bridgewater, N.J.-based medical technology company also gained approval for its 2003 Quality Management System Certification.
The V-Go Disposable Insulin Delivery Device had previously gained FDA approval, and the European CE mark approval now opens it up to a market of approximately 37.5 million adults who suffer from diabetes, more than five million of whom are estimated to use insulin as part of their therapeutic regimen, according to the company. The V-Go provides continuous preset basal rate of insulin and allows for on-demand bolus dosing around mealtimes.
The V-Go Disposable Insulin Delivery Device had previously gained FDA approval, and the European CE mark approval now opens it up to a market of approximately 37.5 million adults who suffer from diabetes, more than five million of whom are estimated to use insulin as part of their therapeutic regimen, according to the company. The V-Go provides continuous preset basal rate of insulin and allows for on-demand bolus dosing around mealtimes.