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NeuroPace Files PMA Supplement to FDA Seeking Expanded RNS® System Indication for Idiopathic Generalized Epilepsy

MOUNTAIN VIEW, Calif., December 17, 2025--NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today announced that it has filed a Premarket Approval Supplement (PMA-S) application to the U.S. Food and Drug Administration (FDA) seeking to expand the labeled indication for its RNS® System to include patients with antiseizure-medication (ASM) resistant idiopathic generalized epilepsy (IGE) with generalized tonic-clonic seizures.

articleNeuropace, Inc.December 17, 20252/company/neuropace-inc/news/neuropace-files-pma-supplement-fda-130000637
NeuroPace Files PMA Supplement to FDA Seeking Expanded RNS® System Indication for Idiopathic Generalized Epilepsy

About this update from Neuropace, Inc.

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NeuroPace, Inc.medical device companyNeuroPaceFood and Drug Administrationliving with epilepsyPMA supplementspatientsRNS SystemBreakthrough Devicesafety profile