NeuroPace FDA Review Delays Expanded Epilepsy Device Approval, Seeks More Data

The U.S. Food and Drug Administration told NeuroPace that its pre‑market approval supplement to broaden the RNS System's indication to medication‑resistant idiopathic generalized epilepsy is not approvable in its current form. The agency asked for additional clinical evidence, including the complete 24‑month dataset from the NAUTILUS trial, deeper analyses of patients with different baseline seizure frequencies, patient‑reported outcomes, stimulation programming details and real‑world evidence.

NeuroPace plans to file a Submission Issue Request to discuss its response with the FDA before amending the supplement. CEO Joel Becker said the company believes a path to approval exists and is working to address the FDA’s questions. Chief Medical Officer Dr. Martha Morrell noted that the FDA’s concerns are not safety‑related; the trial met its primary safety endpoint and no new safety signals were identified.