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Guidance assessment consultation document for HTG10865 Software with artificial intelligence (AI)-derived algorithms to help interpret electroencephalograms (EEGs) for suspected epilepsy: early-use assessment

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2 Information about the technologies

2.1

This assessment included 2 types of software that help healthcare professionals interpret electroencephalograms (EEGs) recorded using scalp electrodes:

  • 4 software technologies (encevis, NeuroCenter EEG, NeuroWorks, Persyst 15) that help healthcare professionals review and interpret EEGs by automatically detecting visual epileptiform activity (such as interictal epileptiform discharges or seizures) on EEGs

  • 1 software technology (BioEP) that helps diagnose epilepsy by classifying EEG recordings without visual epileptiform activity (EEGs considered inconclusive for epilepsy) based on how likely they are to indicate epilepsy.

2.2

The software also provides additional information and features to assist EEG review and interpretation.

Table 1 Features of each software

Software

(company)

Regulatory status

Software type

Intended age group

BioEP
(Neuronostics)

UKCA class I (EU MDR class IIa submission planned for 2027)

Assists epilepsy diagnosis by classifying EEG recordings without visual epileptiform activity based on how indicative they are of epilepsy

18 years and over

Encevis
(AIT Austrian Institute of Technology GmbH)

CE class IIb

Assists reviewing and interpreting EEGs by automatically detecting and marking in EEG data:

  • interictal epileptiform discharges

  • seizures.

18 years and over

NeuroCentre EEG
(Clinical Science Systems)

CE class I (EU MDR class IIa expected in 2026)

Assists reviewing and interpreting EEGs by automatically detecting and marking in EEG data:

  • interictal epileptiform discharges

  • seizures.

6 years and over

NeuroWorks
(Natus Medical)

CE class IIa

Assists reviewing and interpreting EEGs by automatically detecting and marking interictal epileptiform discharges in EEG data

3 months and over

Persyst 15
(Persyst)

UKCA class IIa

Assists reviewing and interpreting EEGs by automatically detecting and marking in EEG data:

  • interictal epileptiform discharges

  • seizures.

  • 1 month and over for spike detection

  • Neonates (conceptional age between 36 and 44 weeks and chronologic age less than 2 weeks) and 18 years and over for seizure detection

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