Cyberonics Treatment IDE To Allow For Limited Use Of VNS For Depression
This article was originally published in The Gray Sheet
Executive Summary
Cyberonics' strategy of obtaining a treatment IDE for its vagus nerve stimulation VNS Therapy for depression will place the device in the hands of more physicians, but will not necessarily help reverse FDA's non-approvable decision
You may also be interested in...
Rejected Device Applicants Conserve R&D Resources, Sidestep Confrontation
Implantable device manufacturers who encountered FDA resistance in 2004 after favorable panel reviews are applying novel premarket data collection techniques to avoid conducting further clinical trials
Rejected Device Applicants Conserve R&D Resources, Sidestep Confrontation
Implantable device manufacturers who encountered FDA resistance in 2004 after favorable panel reviews are applying novel premarket data collection techniques to avoid conducting further clinical trials
Cyberonics Rejects Second ANS Bid, Considers Offer Beneath Self-Appraisal
Advanced Neuromodulation Systems likely would need to up the ante to sway Cyberonics shareholders to accept a takeover bid after CEO Skip Cummins' rejection of initial offers as too low