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Neuraxpharma and mjn-neuro plan to launch EPISERA, an AI-powered epileptic seizure alert wearable, across Europe in Q2 2026. The earpiece sensor continuously monitors brain activity, predicting seizures by analysing electrical patterns, and sends early warnings via a dedicated smartphone app. Designed for home and ambulatory use, EPISERA is the first digital health tool for real-time seizure detection, classified as a Class IIa medical device with a CE mark since 2020.
Neuraxpharma secured exclusive European marketing rights in 2022, covering the EU, UK, Norway, Iceland, Liechtenstein, and Switzerland. A multicentre clinical study, SERAS-Home_RWD (NCT05845255), is ongoing.
The launch marks Neuraxpharma’s entry into digital health; the company also markets Buccolam (midazolam) for emergency seizure treatment. Globally, epilepsy affects around 50 million people, disrupting physical, psychological, and social wellbeing. Competitors in the digital epilepsy space include Australia’s Epiminder, whose Minder implantable EEG device recently received FDA de novo classification.
02-12-2025