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Cyberonics Depression Approval Contingent On Dosing Trial, Registry

This article was originally published in The Gray Sheet

Executive Summary

Cyberonics will start a 450-patient, three-year dosing trial in order to gain PMA approval for its VNS Therapy neuromodulation device for use in treatment-resistant depression patients

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Schultz’ Controversial Approval Of Cyberonics Device Has Little Precedent

CDRH Director Dan Schultz's decision to override device and drug center review staff to approve Cyberonics' VNS Therapy neurostimulation device for treatment-resistant depression has scant precedent in recent history. All the same, he appears to have followed established FDA procedures

Schultz’ Controversial Approval Of Cyberonics Device Has Little Precedent

CDRH Director Dan Schultz's decision to override device and drug center review staff to approve Cyberonics' VNS Therapy neurostimulation device for treatment-resistant depression has scant precedent in recent history. All the same, he appears to have followed established FDA procedures

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