Cyberonics Begins Critical Postmarket MonitoringCyberonics 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.