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NeuroPace, Inc. announced on July 28, 2026, that the U.S. Food and Drug Administration (FDA) issued a not approvable…
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.