The FDA rejected Cyberonics' (CYBX), VNS nerve stimulation device for use in patients suffering from severe depression this morning. As I and others have said all along, the data supporting the efficacy of the VNS device in depression was weak, to put it mildly. The FDA obviously agreed, overruling a recommendation for approval from an advisory panel held in May.The company's press release basically blasted the FDA's decision in some very angry terms. But in the end, it seems as if negative data, and not emotion, spin and arm twisting, wins this battle.
FDA Rejects Cyberonics' Device
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