New disposable diabetes insulin device receives further approval

The V-Go Disposable Insulin Delivery Device for adults suffering from type 2 diabetes has received the CE Mark approval for sale in the European Economic Area (EEA). The device, which is manufactured by medical technology company Valeritas, Inc in the United States, provide basal-bolus therapy for adults who are in need of insulin therapy .
It is thought there are around five million patients in the EEA who use insulin as part of their therapeutic regimen, out of about 37.5 million diabetics adults in the region. In addition, the small, lightweight device has received the ISO 13485: 2003 Quality Management System Certification.
The V-Go system offers a continuous preset basal rate of insulin and provides for on-demand bolus dosing around mealtimes. The use of such a device is intended as an alternative to having to take multiple daily insulin injections .
Kristine Peterso, chief executive at Valeritas, commented “These are important corporate milestones for Valeritas as we evaluate the commercialization of the V-Go outside of the United States.”
She added “The CE Mark, coupled with our FDA 510(k) clearances in December 2010 and February 2011, affords us the opportunity to provide an innovative therapeutic option to the millions of adults who require insulin to treat their diabetes .”