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Last Updated: Thursday, October 1, 2026 at 06:52 PM
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FDA approves implant for depression

U.S. regulators have given conditional approval to Cyberonics Inc.’s  application to market an implanted device to treat depression, the company said.

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.