FDA Approves Implant for Depression Treatment

Posted by Wildflower on February 3, 2005, at 10:38:52

Pacemaker-like device delivers electrical impulses to brain
Updated: 7:52 p.m. ET Feb. 2, 2005
LOS ANGELES - U.S. regulators have given conditional approval to Cyberonics Inc.’s application to market an implanted device to treat depression, the company said Wednesday.
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.

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FDA Approves Implant for Depression Treatment Wildflower 2/3/05
Re: FDA Approves Implant for Depression Treatment » Wildflower Phillipa 2/3/05
Re: FDA Approves Implant for Depression Treatment » Wildflower KaraS 2/4/05
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