SetPoint Medical

SetPoint Medical specializes in an implantable vagus nerve stimulation system designed for antiseizure and psychiatric therapy. This includes the core implantable device that stimulates the vagus nerve, as well as associated accessories like a docking station, charger, programmer, and software for managing stimulation parameters. The system is intended to provide therapeutic electrical stimulation for neurological and psychiatric conditions.

SetPoint Medical is based in the United States. While the company’s regulatory filings and device listings (such as FDA’s PMA and UDI database) reflect its primary focus on the US market, the specific availability of its devices in other countries would depend on local regulatory approvals, which are not addressed in the provided data.

SetPoint Medical’s vagus nerve stimulation system is classified as Class III under FDA regulations. This classification requires a Premarket Approval (PMA) due to the device’s high-risk nature, as it involves implantable technology with potential life-sustaining or life-supporting implications. Class III devices also mandate inclusion in the FDA’s Unique Device Identifier (UDI) database to ensure traceability and regulatory oversight.

SetPoint Medical’s devices are listed in the FDA’s Premarket Approval (PMA) database and the FDA’s Unique Device Identifier (UDI) database. These registries reflect the device’s regulatory status in the United States, where the company operates. The PMA process ensures the device meets stringent safety and effectiveness standards before commercialization, while the UDI system provides standardized identification for tracking and compliance.