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FDA rejects NeuroPace's request to expand RNS System indication, citing need for additional clinical evidence from NAUTILUS trial
NPCENeuroPace Inc
NeuroPace, Inc. announced on July 28, 2026, that the U.S. Food and Drug Administration (FDA) issued a not approvable letter for its Premarket Approval Supplement (PMA-S) seeking to expand the RNS System indication to include patients with antiseizure medication-resistant idiopathic generalized epilepsy (IGE) with generalized tonic-clonic seizures. The FDA requested additional clinical evidence, specifically data from the NAUTILUS trial and supporting literature, before the submission can be approved. NeuroPace intends to submit a Submission Issue Request to discuss the path forward and continue collaborating with the FDA. The company reported that 18-month NAUTILUS results showed a 77% median reduction in GTC seizures, with 40% of patients achieving seizure freedom. NeuroPace operates in the medical device industry, developing the RNS System for the treatment of drug-resistant epilepsy.