FDA greenlights Motif Neurotech's feasibility trial of brain-implant hat for treatment-resistant depression

The U.S. Food and Drug Administration has approved Motif Neurotech's request to begin an initial feasibility trial of its brain‑implant device aimed at patients with treatment‑resistant depression.

The device, roughly the size of a blueberry, is implanted in the skull and is activated by a specially designed hat that delivers a brief electrical pulse to targeted brain regions.

The trial will assess safety and preliminary efficacy of the implant in a small cohort, marking the first human testing step for the company's novel approach to managing depression that has not responded to conventional therapies.