Cyberkinetics, Inc, winner of the Medgadget "Most Sci-Fi Sounding Company Name" Award, has asked the FDA for permission to market their Andara OFS nerve growth stimulation system.
According to Cyberkinetics, “Cyberkinetics' Andara™ OFS™ System consists of a battery-powered device about the size of a cardiac pacemaker with six electrical leads. Three of the leads are attached to the vertebrae at a distance of two disk-segments above the area of injury, and three are attached to the vertebrae at a distance of two disk-segments below the injury. By applying an oscillating, low-voltage, direct current of electricity to the areas above and below a spinal cord injury, the Andara™ OFS™ System creates an electrical field that surrounds the injury and stimulates the nerves surrounding the spinal cord to grow and form new connections that can restore sensory and motor function. The Andara™ OFS™ System is an investigational device. It is not currently approved for sale and is available only through participation in a clinical study.Cyberkinetics has filed an application for Humanitarian Use Device status from the FDA. If the application is successful, Cyberkinetics could market the device commercially in late 2007.
Basically, the new humanitarian exemption would mean that they could actually sell the device, rather than only use it through clinical trials.
Source-Bio-Bio Technology
SRM
