Press release - March 19th, 2010
cerbomed gets CE labeling for transcutaneous vagus nerve stimulator
Erlangen, March 19th, 2010. cerbomed gmbh, a start-up company in the area of neurostimulation, today announced that its transcutaneous vagus nerve stimulator now has the CE label for use for the indications of depression and epilepsy, and is approved for sale in the European Union.
This milestone in the certification of the young enterprise clears the way for marketing and sales in the 25 EU member states. The transcutaneous vagus nerve stimulator, developed by cerbomed, is the first and only device with a CE label for transcutaneous vagus nerve stimulation (t-VNS). It is approved for treating depression and epilepsy, and is an innovative alternative therapy for affected patients.
"We are proud to have received the CE label. This is an essential step preparing the market launch of our innovation,” says Dr. Andreas Hartlep, Chief Technology Officer (CTO) at cerbomed.
The CE label of a product shows that it meets the strict quality, design and performance standards required by EU guidelines for all medical products sold in Europe. cerbomed gmbh obtained the CE label after a comprehensive audit of its product design dossier, and data from clinical trials, as well as the successful completion of an inspection of its facilities.
cerbomed is a young, medical device company focusing on the research, development and manufacturing of innovative technologies and products in the area of neurostimulation. Its major proprietary procedure, transcutaneous vagus nerve stimulation (t-VNS), will offer a new, alternative treatment for various neuropsychiatric disorders with clinical benefit and improved quality of life at a superior cost benefit ratio.
Since its foundation in December 2005, cerbomed has received many innovation and new enterprise prices (including university- and chamber of commerce new enterprise awards), and was among the federal winners of the German new enterprise prize in 2006.