FDA Panel Criticizes Neurostar Depression Device

According to a report on CBS News, an FDA advisory panel who met last Friday to discuss a new depression treatment device called Neurostar offered a critical assessment of its ability to help depressed patients, damaging its chances for FDA approval.

Neurostar is a device which administers a treatment called transcranial magnetic stimulation, or TMS, in which a focused magnetic field is sent into the brain. The device is described as being similar to a dentist's chair with metal prongs attached to a nearby console.

TMS has been offered as a gentler alternative to electroconsulsive therapy (ECT) because it works in a similar manner, by inducing a seizure, but produces fewer side-effects.

Unfortunately this new device may never receive FDA approval given the advisory panel's doubts about its effectiveness. Among the criticisms made against the device was the fact that patients showed no improvement on some depression scales and only minor improvement when there was a difference. The panelists questioned whether the difference was significant enough to show that the device actually worked.