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Zack Lynch Zack Lynch is the founder and executive director of the Neurotechnology Industry Organization (NIO) and co-founder of NeuroInsights. He serves on the advisory boards of the McGovern Institute for Brain Research at MIT,Center for Cognitive Liberty & Ethics, the InnerSpace Foundation, the Center for Neuroeconomic Studies and SocialText, a social software company. His book on how brain science is changing our world will be available July 2009. Please send newsworthy items or feedback - to Zack Lynch.
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February 3, 2005

Cyberonics Neurodevice Receives Approval Recommendation For Depression

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Posted by Zack Lynch

Correction: The FDA didn't approve the device yet, the panel recommended approval after they meet certain requirements for labeling, protocols for dosing, and a few other things - final approval/launch expected in late May.

Cyberonics shares soared Thursday after the FDA reversed an earlier decision and approved its experimental treatment for depression. The neurodevice company's pacemaker-like device, which is surgically implanted into a patient, has been available in the U.S. since 1997 as a treatment for epilepsy. The Vagus Nerve Stimulation Therapy System was approved as a long-term adjunctive treatment for patients over the age of 18 with chronic or recurrent treatment-resistant depression in a major depressive episode that has not responded to at least four adequate antidepressant treatments.

This highlights an important trend in the emerging neurotechnology industry:
neurodevices and neuropharmaceutical companies will increasingly compete for market share as they strive towards developing for better tools to treat mental illnesses. Indeed, Cyberonics already has pilot studies underway to evaluate VNS Therapy as a potential treatment for anxiety disorders, Alzheimer’s disease and chronic headache/migraine.

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