510(k) for Radionics' NeuroMap system:
This article was originally published in Clinica
Executive Summary
The FDA has cleared Radionics' NeuroMap system for functional neurosurgery. It is designed to treat patients with movement disorders, in particular Parkinson's disease, by allowing doctors to precisely locate brain structures such as the pallidum and thalamus. The system analyses electrical signals in the brain to target these structures before treatment is performed. NeuroMap forms part of the NeuroPlan package developed by the Burlington, Massachusetts-based company.