The NeuroPace RNS System is the first FDA-approved closed-loop brain stimulation device, designed specifically for drug-resistant focal epilepsy. A neurostimulator the size of a matchbook is implanted in a cranial recess; up to two leads with strip or depth electrodes are placed at seizure foci. The device continuously monitors cortical EEG in real time, detects abnormal electrical patterns indicative of impending seizures, and automatically delivers brief counter-stimulation pulses without patient action. Long-term data from the RESPONSE trial shows a median 75% reduction in seizures at 9 years post-implant, with some patients achieving seizure freedom.
This device does not have a current FDA designation. It may be a research tool, preclinical device, or consumer product not subject to FDA medical device regulation.
FDA Device Regulatory Guidance ↗