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Cyberonics Begins Critical Postmarket Monitoring

One of last year's most controversial stories was when FDA approved Cyberonics, Inc.'s Vagus Nerve Stimulation Therapy for treatment-resistant depression. Some FDA reviewers questioned its value and accused CDRH Director Daniel Schultz of railroading the application through. But the decision was correct, and so is the move to do significant postmarket monitoring.

In a release available on, Cyberonics today announced that enrollment in a patient registry has begun at 22 medical centers. In a few years, we should have a better understanding of what drives treatment-resistant depression and how nerve stimulation therapy can help.

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