FDA clears first US trial of wireless brain implant for treatment-resistant depression

The FDA has cleared Motif Neurotech to begin the first U.S. clinical trial of its wireless brain implant for treatment-resistant depression.

The DOT device delivers programmable electrical stimulation above brain tissue and will be tested in an early feasibility study at several U.S. medical centers.

The trial marks the first U.S. human test of a minimally invasive, wireless implant for depression that has not responded to standard care.

If successful, the approach could offer a new treatment path for millions of patients with difficult-to-treat depression.