FDA Rejects NeuroPace Label Expansion for Epilepsy Implant

The company confirmed it has already met with federal regulators to discuss the rejection and intends to file a submission issue request. Despite the regulatory setback, clinical data for the device remains strong. Patients using the RNS System reported a 77% median reduction in generalized tonic-clonic seizures compared to baseline after 18 months, with 40% of participants achieving complete freedom from these seizures.

NeuroPace also provided two-year follow-up data at the agency’s request, documenting sustained improvement among patients who utilized stimulation for 23 of the 24 months post-implantation. Following the announcement, the company’s stock price slid to $12.99 in after-hours trading, extending a 9% decline observed over the previous three months.