EU Okays AI-Powered Epileptic Seizure Warning Device for 2026

A new AI-powered device that warns epilepsy patients ahead of seizures is set to launch in Europe by 2026. The device will warn epilepsy patients and their caregivers minutes before seizures occur to avoid unpleasant surprises.

Developed by Neuraxpharm and Spanish start-up mjn-neuro, the device is an AI-powered earpiece that uses advanced algorithms to continuously record brain activity and use it to predict occurrence of the next seizure.

The device sends warnings to its users through an app on their mobile phone when the risk of seizure is heightened to enable them to act appropriately. This way, there are no unwanted surprises due to sudden seizures.

Seizure Warning Device Marks Milestone in Epileptic Care

According to the Epilepsy Foundation, Epilepsy is a brain disorder that causes recurring, unprovoked seizures. It is a common disorder that affects 1 in 26 people worldwide and while it does not prevent victims from work or other engagements, it can be embarrassing and dangerous when seizures come suddenly.

One study indicates that 55% of seizures by epilepsy patients resulted in a motor accident, which makes it an important cause of road accidents. While some epilepsy conditions can be treated with medication, others can be drug-resistant and it is for this category that the device was invented.

It provides timely warnings that help reduce accidents and improve autonomy as well as support patients and caregivers with ongoing out-of-hospital monitoring to prevent sudden and potentially dangerous seizure bouts.

The device is the first designed for real-time early detection of seizures that can be used at home and outdoors. Certified in Europe as a Class IIa medical device (CE mark) and also holding UKCA approval, it is undergoing clinical study in Spain, the UK and Germany after which it will be released.

Ten Years of Work Offers Solution to Epilepsy

Devices created by research may seem common and easy to make, but many times they take several years of work, and this device is no different. According to the CEO and Co-Founder of mjn-neuro, the device is a culmination of more than a decade of development.

He adds that it has successfully passed several clinical trials and demonstrated solid clinical evidence of effectiveness for preventing sudden seizures. According to the schedule, the device will be launched by the second quarter of 2026.

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