Epilepsy diagnosis tool gets MHRA approval

Published: January 04 2024
Last updated: March 26 2024

Grace Wood | A digital tool to help doctors with epilepsy diagnosis has been approved by the MHRA

The epilepsy diagnosis tool has been created by Neuronostics

A technology that can help doctors diagnose epilepsy has been approved in the UK.

The clinical decision tool, which can be used as additional evidence by medical professionals, was awarded a UKCA mark in December 2023.

BioEP has been developed by a firm called Neuronostics, which says results can be produced in 15 minutes. It is listed as a Class I medical device, meaning it is low-risk.

It speeds up the diagnosis by using background EEG results to identify the likelihood of future seizures.

According to Neuronostics, average clinical diagnosis of epilepsy currently takes more than a year.

BioEP was awarded the UKCA mark by the government’s Medicines and Healthcare products Regulatory Agency (MHRA). The mark indicates that a product meets the requirements to be sold in the UK.

The regulatory upgrade to UKCA included a thorough clinical evaluation, literature review and usability evaluations by clinicians.

Neuronostics managing director John Terry said: “I am delighted that we have been able to deliver this key regulatory milestone.

“Our entire team has worked collaboratively towards this achievement, ensuring that the Neuronostics Platform meets the robust standards laid out as part of a UKCA mark.

“This UKCA marking provides our partners, collaborators and clinicians with the confidence that we have developed a safe, effective and clinically valuable product.”

The UKCA mark replaced the CE mark in the UK, which was the European Union equivalent. BioEP also has CE certification.

This year, Neuronostics hopes to achieve FDA approval for BioEP, which will also allow it to be used in the USA.

The firm has also begun a prospective clinical trial of BioEP. The randomised study will measure time to diagnosis and accuracy. It will include 559 participants and conclude in February 2027.