May 2026 NeuroPace received U.S. FDA approval for ECoG Assistant™, its first AI-enabled clinical decision support tool for the RNS® System, enhancing intracranial EEG review and supporting more efficient epilepsy monitoring and treatment decisions.
November 2025 Ceribell received U.S. FDA 510(k) clearance for its Infant Seizure Detection Software, expanding its AI-powered EEG platform with automated seizure detection capabilities for neonatal and infant patients.
May 2025 LivaNova received U.S. FDA approval for a design enhancement to its VNS Therapy® System, replacing the reed switch with a giant magnetoresistor sensor to improve the reliability of magnet-mode activation for patients with drug-resistant epilepsy.
May 2025 NeuroPace received U.S. FDA approval for an updated RNS® System component, incorporating a new battery material supplier to strengthen the manufacturing and long-term reliability of its responsive neurostimulation device for epilepsy treatment.