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RNS SystemNeuroPace—NeuroPace presents NAUTILUS trial data showing 77% seizure reduction for generalized epilepsy at AANRNS SystemNeuroPace—FDA requests additional evidence on RNS System IGE indication; NeuroPace plans resubmission

RNS System

by NeuroPaceUS

Closed-loop brain implant that monitors electrical activity and delivers stimulation when seizure patterns detected. Personalized for each patient's seizure signature.

DeployStage 4 of 5

FDA approved focal epilepsy November 2013. NAUTILUS 77% GTC reduction; awaiting IGE approval.

Updated Jul 2026Checked 10 Oct0 updates this week

Milestones

Next · FDA consideration of NAUTILUS supplement for IGE indication
  1. RNS System FDA approval for drug-resistant focal epilepsyNov 2013Complete.
  2. Breakthrough Device Designation for generalized epilepsyMar 2021Complete.
  3. NAUTILUS trial 12-month interim dataJun 2025Complete.
  4. NAUTILUS 18-month data presented at AANApr 2026Complete.
  5. FDA consideration of NAUTILUS supplement for IGE indicationTarget Q4 2026Not yet reached.

Most important updates

Upcoming

  1. Q4 2026FDA consideration of NAUTILUS supplement for IGE indication (next)
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