Requests by FDA likely to delay Cyberkinetics nerve-growth stimulator

12/11/2007 | American City Business Journals

The FDA has asked Cyberkinetics Neurotechnology Systems to provide additional analyses and data on Andara, its implantable device that stimulates nerve growth in patients with acute spinal-cord injuries, before it grants a humanitarian device exemption for the product. The agency's additional requests are expected to delay the approval of the device until the first half of next year, the company said.

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