News & Press
NeuroPace RNS System receives FDA approval for pediatric epilepsy down to age 12
MedPage Today4/16/2026·04/16/26🌐 USA
Summary
NeuroPace received FDA approval to expand the RNS System indication to adolescents aged 12 and older with drug-resistant focal epilepsy, based on a 20-patient safety study showing comparable adverse event rates and efficacy to the adult population. This is the first closed-loop responsive neurostimulation device approved for pediatric use in the US.
Why it matters
Pediatric epilepsy affects 3.4 million children in the US with 30% refractory to medication. Expanding closed-loop RNS to age 12 gives this population access to the most sophisticated epilepsy neuromodulation technology — previously only available to adults.
#Epilepsy#Closed-Loop#Neurostimulation#FDA#USA
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