British Health Minister Calls for Tougher Medical Device Regulation
Lord Philip Hunt, the U.K.'s Health Minister, called for tougher reforms and new regulations for the European medical device industry. Speaking at a conference of the U.K. Medical Device Agency, Hunt spoke of some serious shortcomings with current safety regulations for medical devices. The European Union's Medical Devices Directive currently is responsible for approval of medical devices in Europe. Many neurotechnology manufacturers have found it easier to obtain CE mark clearance than FDA approval in the U.S. Among the manufacturers who have had products approved in Europe before obtaining FDA approval are NeuroControl, Advanced Neuromodulation Systems, Cyberonics, and Med-El.

Neuropathy Association Forms Branch in Italy
The Italian Neuropathy Association has been formed as an affiliate of the New York-based Neuropathy Association. The Italian organization, to be based at the University of Padova, is the first such group in Europe. Neuropathy is a serious condition resulting from degeneration of peripheral nerves, causing severe pain and disability. Though it affects about 20 million people in the U.S. alone, neuropathy is not well known among the public. Several neurodiagnostics manufacturers market products that help identify the condition and several neurostimulation firms are investigating neuromodulation treatment.

U.C Davis Plans $40 Million Autism Facility
The University of California, Davis recently broke ground for a new $40 million facility for research and treatment for children with autism ad othe neurodevelopmental disorders. The 135,000 sq. ft. MIND Institute (for Medical Investigation of Neurodevelopmental Disorders) will include an outpatient clinic, exam rooms, and a resource center/library.

Med-El Receives FDA Approval, Begins Bilateral Tests
Med-El Corp., the Austrian based manufacturer of cochlear implants, received FDA approval for its COMBI 40+ cochlear implant, joining Cochlear Corp. and Advanced Bionics as competitors in the U.S. market. Med-El has been selling largely in the European market previously. Med-El also announced that it has begun testing bilateral implants with its device. Dr. Philip Wackym of Froedert Hospital and Medical College of Wisconsin implanted two patients with COMBI 40+ devices in both ears.

Cyberonics Completes Test of VNS for Treating Depression
Cyberonics Inc. announced that the company had completed its 235-patient Phase III testing of its NCP vagus nerve stimulation system for treatment of depression. The company expects to have results from the test by March and hopes to complete its PMA application by June. Included in the research program are neuroimaging and neurochemical analyses to research the mechanism of action, plus health economics and cost studies.