New York University

Motif Neurotech Receives FDA Approval for First Clinical Trial of Wireless Brain Implant for Treatment-Resistant Depression

- Motif Neurotech received FDA approval for the RESONATE early feasibility study to test its XCS System, a wirelessly-powered brain implant for treatment-resistant depression. - The blueberry-sized device delivers electrical stimulation to brain regions without direct brain contact, activated by wearing a baseball hat-like external component. - The trial will evaluate safety and efficacy in patients who have not responded to two or more medications across eight leading medical institutions. - Nearly 3 million Americans live with treatment-resistant depression, representing a significant unmet medical need for this novel brain-computer interface approach.