The U.S. Food and Drug Administration (FDA) has cleared MRI conditional labeling for medical technology company NeuroPace's RNS system for epilepsy.
NeuroPace's RNS system is an adjunctive therapy for individuals with focal onset seizures. It consists of an implantable neurostimulator with leads placed at the site of seizure onset, a remote monitor for patients to upload their data, and patient data management software for physicians.
With the clearance, patients with the RNS system are now authorized to undergo full-body 1.5-tesla MRI.