18th December 2023
We are thrilled to announce, we have regulated our Neuronostics Platform with the MHRA, delivering BioEP™ capabilities under UKCA. An upgrade to our previous CE marking, to incorporate BioEP™’s new features, including the 6 criteria for interictal epileptiform discharges proposed by the IFCN in 2017.
This Regulatory upgrade included a thorough clinical evaluation, literature review, usability evaluations with neurologists, neurophysiologists and epilepsy nurses, risk management, and full design control process.
The Neuronostics Platform is a clinical decision support system that analyses EEG data and indicates whether the analysis of a patient’s EEG is supportive of epilepsy or unsupportive, supporting the case for a differential diagnosis.
BioEP™ uses routinely collected EEG recordings gathered as part of the patient’s diagnostic journey, and computationally analyses the EEG for the presence of data features and brain network-based markers (i.e. digital BIOmarker of EPilepsy) that are shown in published literature to be elevated in people with epilepsy.
The BioEP™ analysis helps to differentiate between brain networks typical in people with and without epilepsy. The BioEP™ report, therefore, acts as an additional piece of evidence to support clinicians in the process of diagnosing people with suspected epilepsy and determining the best next steps.
Neuronostics Managing Director, John Terry “I am delighted that we have been able to deliver this key regulatory milestone.
“Our entire team have 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.”