Overview
- Motif Neurotech said Monday the FDA granted an Investigational Device Exemption for RESONATE, clearing first-in-human testing of its depression implant.
- The authorization covers a small safety study of about 10 people at up to eight U.S. sites with 12 months of follow-up after surgery, not approval for general use.
- The DOT/XCS is a blueberry-sized implant set into the skull above the brain that avoids tissue contact and can be placed in a roughly 20-minute outpatient procedure.
- A wireless cap powers the implant and sends the prescribed stimulation dose, enabling 10 to 20 minute home sessions several times a day at first.
- The program builds on a decade of Rice University research backed by DARPA, ARPA‑H, and the NIH BRAIN Initiative, and the company says it reached IDE four years after founding.