Quick FDA review for depression treatment:
This article was originally published in Clinica
The US FDA has told Cyberonics that it will review the company's premarket approval application for a nerve stimulator to treat depression under expedited review status. The Houston, Texas-based company has yet to start its randomised clinical trial of the NCP system, but has submitted an investigational device exemption with the FDA. The trial is likely to take two to three years to complete, said the company. The NCP device is already sold in the US to treat epilepsy and has proved popular with physicians (see Clinica No 812, p 13).