Motif Neurotech's DOT is a blueberry-sized (9mm wide), leadless, batteryless implantable brain stimulator placed in the skull during a 20-minute outpatient procedure without ever exposing or contacting the brain. Receives data and power wirelessly from an external cap-like device via patented magnetoelectric power transfer technology developed at Rice University. Provides cell-type specific stimulation and electrical recording to regulate brain-wide circuits. Multiple DOTs can be networked to span the cortical surface for bilateral or multi-region stimulation. First product targets treatment-resistant depression. Intraoperative human studies demonstrated safe and effective stimulation, with 30+ day large animal studies completed.
An IDE permits a device to be used in a clinical study to collect safety and effectiveness data required for a PMA or 510(k) submission. IDE devices are not approved for commercial sale.
FDA Device Regulatory Guidance ↗