FDA ADVISORY PANEL DEEMS DEVICE SAFE, BUT NOT NECESSARILY EFFECTIVE

An FDA advisory panel Jan. 26 was unable to give its vote of confidence to a new device meant to treat severe depression.

Because the panel was assessing a premarket notification application, or 510(k), for Neuronetics' transcranial magnetic stimulation (TMS) device, it was not charged with voting on a possible approval but rather reviewing the device's safety, effectiveness and balance of risks to benefits.

Over the course of its deliberations, the panel achieved a consensus that, while the Neurostar TMS device was probably safe, existing clinical trial data fell short of delivering conclusive data on the product's effectiveness in patients with major depressive disorder.

An FDA spokeswoman did not say when the agency would make a final decision on approving the device, although she noted that 510(k) decisions tend to be speedier than those on premarket approvals. Neuronetics said it expects a decision within the next few months.