For healthcare professionals
An objective, interpretive EEG assessment aid for the diagnosis of mild traumatic brain injury — developed, verified and validated to perform as intended.
How it works
Nurochek-Pro measures the brain's steady-state response to visual stimulation — a signal that does not depend on patient self-report — and interprets it as an adjunct to standard neurological assessment.
A non-invasive recording captures the steady-state visual evoked potential (SSVEP) response.
The reading is compared against a reference database within a validated classification model.
The result supports clinical judgement when used alongside a standard neurological assessment.
Clinical validation
Clinical evaluation concluded that the device performs as intended for its labelled purpose. Nurochek-Pro demonstrated the following performance when used as an adjunct to standard neurological assessment.
87.37%
Sensitivity
95% CI 78.97–93.30
64.56%
Specificity
95% CI 56.56–71.99
75.96%
Balanced accuracy
Sensitivity & specificity, averaged
Reported figures
Point estimates with 95% confidence intervals from clinical evaluation.
| Sensitivity [95% CI] | Specificity [95% CI] | Balanced accuracy |
|---|---|---|
| 87.37%95% CI 78.97–93.30 | 64.56%95% CI 56.56–71.99 | 75.96% |
Study population
Participant demographics from clinical evaluation of the Headsafe mTBI classification model. Two research groups were included: post-episode injured non-concussed participants (PE) and clinically concussed participants (CNXO).
12–44
Age range (years)
Labelled indication band
≈20yr
Median age
Comparable across groups
Predictive value
Positive and negative predictive value depend on how common mTBI is in the population assessed. At a reference prevalence of about 38%, Nurochek-Pro showed the values below.
Quality & regulatory
The Nurochek-Pro System has undergone design verification and validation under Headsafe's quality management system.
Quality management system certified by Intertek for medical devices.
Within the scope of a Medical Device Single Audit Programme quality system.
Indicated as an adjunct to a standard neurological assessment by a clinician.