U.S. regulators have given conditional approval to Cyberonics Inc.’s application to market an implanted device to treat depression, the company said Wednesday.
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The VNS Therapy System is a pacemaker-like device that delivers electrical impulses to the brain. Cyberonics already sells the implant for reducing seizures from epilepsy.
The FDA said approval was conditional on final labeling, protocols for a post-marketing dosing study and patient registry as well as compliance with quality system regulations and resolution of any outstanding monitoring issues.














