FDA clears Epiminder's implanted EEG monitor for adolescents with drug-resistant epilepsy
The expanded clearance lowers the Minder system's minimum age from 18 to 12, giving teenagers access to continuous EEG recorded outside the hospital.
The FDA has expanded clearance of Epiminder’s Minder system to people with drug-resistant epilepsy aged 12 and older, the company announced on October 30. It was previously limited to adults 18 and older. Minder uses an electrode array placed under the scalp, without penetrating the skull, and a telemetry unit behind the ear. A wearable charges the implant and sends continuous EEG to a cloud platform for remote review.
The change gives teenagers an alternative to relying on seizure diaries and short hospital stays, the company and an outside epilepsy specialist quoted in the release say. Minder monitors seizures and does not treat them. Epiminder recently reached 100 participants in a separate US study.