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Cyberkinetics’ Andara for spinal cord injuries

This article was originally published in The Gray Sheet

Executive Summary

Humanitarian device exemption application will be filed "later this year" by Cyberkinetics Neurotechnology Systems for use of its Andara oscillating field stimulator to promote nerve fiber regeneration and treat acute spinal cord injuries, the firm says Sept. 6. FDA has designated the system a humanitarian use device. The stimulator is intended for use within 18 days of injury to improve or restore tactile sensation and some movement in patients with quadriplegia and tetraplegia. The HDE submission will be supported by animal data and a 10-patient clinical study. Future, expanded applications may include treatment of peripheral nerve injuries, strokes and traumatic brain injuries...
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