FDA requests additional evidence on RNS System IGE indication; NeuroPace plans resubmission

NeuroPace/RNS System

The FDA did not approve NeuroPace's bid to expand the RNS System for medication-resistant idiopathic generalized epilepsy, requesting additional clinical evidence, information and real-world data. NeuroPace plans to seek FDA alignment before submitting an amendment with the complete 24-month NAUTILUS dataset and patient-outcome context.