Neuraxpharm and mjn-neuro Launch AI-Powered Wearable Device for Early Epileptic Seizure Detection
Key Insights
Neuraxpharm (search) and mjn-neuro (search) announce the upcoming European launch of Episeras (search), an AI-powered wearable earpiece that predicts epileptic seizures minutes before they occur.
The device targets patients with drug-resistant epilepsy (search), affecting approximately 30% of all epilepsy (search) patients, and provides real-time brain (search) activity monitoring through advanced artificial intelligence algorithms.
Episeras (search) has received CE mark and UKCA certification as a Class IIa medical device, with European market launch scheduled for the second half of 2026.
Neuraxpharm (search) Group, a leading European specialty pharmaceutical company focused on central nervous system (CNS) disorders, and Spanish digital health start-up mjn-neuro (search) have announced the upcoming launch of Episeras (search), a groundbreaking AI-powered wearable device designed to predict epileptic seizures in real time. The innovative digital health solution represents a significant advancement in epilepsy (search) management, particularly for patients with drug-resistant forms of the condition.
Revolutionary Technology for Seizure Prediction
Episeras (search) is a non-invasive digital medical device that continuously monitors brain (search) activity through a discreet, wearable earpiece sensor. The device utilizes advanced artificial intelligence algorithms to analyze electrical patterns in the brain, identifying when a seizure is likely to occur and sending alerts minutes before the event when risk levels are elevated.
The Bluetooth-enabled earpiece features a custom-designed, 3D-printed brain (search) activity sensor that communicates with a dedicated mobile application. This app analyzes and displays seizure-risk data and notifications, providing comprehensive support for patients and caregivers in daily monitoring activities.
Targeting Drug-Resistant Epilepsy
The solution is specifically intended for patients with drug-resistant epilepsy (search), a condition that affects approximately 30% of all epilepsy (search) patients and is even more prevalent in childhood-onset disorders. Drug-resistant epilepsy is defined as persistent seizures despite trying at least two types of anticonvulsant medicines (search) at prescribed doses.
According to the companies, Episeras (search) provides patients with valuable warning time to move to a safe place or notify caregivers, potentially preventing accidents and improving safety in daily life. The device represents the first digital health solution for real-time early detection of seizures available for both ambulatory and homecare use.
Clinical Validation and Regulatory Approval
The medical digital solution has already been validated and certified in Europe as a Class IIa medical device, holding both the CE mark and UKCA certification. A multicentre, prospective clinical study called SERAS-Home_RWD is currently underway across three countries—Spain, the United Kingdom, and Germany. Interim data from this study is being prepared for publication.
David Blánquez, chief executive officer and co-founder of mjn-neuro (search), emphasized the extensive development process: "Our team has been developing this pioneering project for more than ten years, and thanks to the results obtained from several clinical studies, mjn-neuro has successfully demonstrated solid clinical evidence supporting its effectiveness."
Strategic Partnership and Market Launch
The European launch of Episeras (search) is scheduled to commence in the second half of 2026, marking a key milestone in Neuraxpharm (search)'s strategic entry into the medical devices and digital health space. This initiative builds upon Neuraxpharm's comprehensive portfolio of anti-epileptic treatments and formulations, expanding their commitment to epilepsy (search) management through innovative, non-pharmacological tools.
Dr. Jörg-Thomas Dierks, chief executive officer of Neuraxpharm (search), stated: "At Neuraxpharm, we are dedicated to improving the lives of people with CNS disorders through continuous innovation and strong partnerships. With this launch, we are taking another important step in our journey to improve the daily lives of people with epilepsy (search)."
Beyond the Pill Strategy
The collaboration represents Neuraxpharm (search)'s pursuit of a 'beyond the pill' strategy, combining drug therapies for CNS disorders with digital health technologies and medical devices. The partnership with mjn-neuro (search), first established in 2022, marked Neuraxpharm's initial concrete step in this strategic direction.
The platform has been developed with support from the EU's European Institute of Technology Health (EIT Health) and funding from the Horizon 2020 programme, along with contributions from industrial and academic partners. This comprehensive support structure underscores the significant potential of the technology to transform epilepsy (search) care across Europe.