November 2025 The U.S. FDA approved expanded labeling for Medtronic DBS Therapy for Dystonia, extending its indication to include pediatric patients aged 12 years and older with generalized dystonia that is refractory to medication. This represents one of the most significant recent regulatory developments in pediatric neuromodulation devices.
November 2025 The U.S. FDA granted 510(k) clearance to Ceribell Infant Seizure Detection Software, an AI-enabled electroencephalography (EEG) solution designed to assist clinicians in detecting seizures in infants, supporting earlier diagnosis in neonatal intensive care units (NICUs).
July 2025 The FDA Pediatric Advisory Committee conducted its annual post-marketing safety review, including pediatric neurological devices such as the Medtronic Activa Neurostimulator for Dystonia, reinforcing continued regulatory oversight of pediatric neurology technologies.
June 2025 The U.S. FDA granted 510(k) clearance to Empatica's EpiMonitor, a physiological signal-based seizure monitoring system for epilepsy. The wearable technology expands continuous seizure monitoring capabilities and can support pediatric epilepsy management where clinically appropriate.