Motif Neurotech Secures FDA IDE for Brain Implant TRD Trial

Motif Neurotech obtained FDA Investigational Device Exemption for the RESONATE early feasibility study of its XCS System, a blueberry-sized wireless implant called DOT that delivers electrical stimulation to a brain region linked to depression symptom reduction. The device sits in the skull bone without contacting brain tissue and is implanted via a 20-minute outpatient procedure. The 12-month study at eight sites including Baylor College of Medicine and Massachusetts General Brigham will assess safety post-implantation, reductions in depression symptoms via clinical scales, and changes in quality of life, anxiety, and cognition. This approval marks Motif as the fastest implantable BCI company to reach IDE with a novel device since its founding four years ago.