INTRODUCING NUROCHEK
Nurochek is an FDA-cleared medical device that provides an objective concussion assessment in just 2 minutes.
Rapid (2mins)
Objective
Affordable
Baseline-free
Easy-to-use
Portable
The Nurochek-Pro System is intended for prescription use in healthcare facilities for subjects aged between 12 and 44 years old, for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment, FDA-cleared on March 2025.
The Nurochek-Pro System is indicated for the generation of visual evoked potentials (VEP) and to acquire, transmit, display, and store electroencephalograms (EEG) during the generation of VEPs. Additionally, system is indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain injury (mTBI) in subjects aged between 12 and 44 years old who have sustained a potential head injury in the past 120 hours (5 days).
The Nurochek-Pro System is indicated for the generation of visual evoked potentials (VEP) and to acquire, transmit, display, and store electroencephalograms (EEG) during the generation of VEPs. Additionally, system is indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain injury (mTBI) in subjects aged between 12 and 44 years old who have sustained a potential head injury in the past 120 hours (5 days).
LEADING THE RACE IN
CONCUSSION ASSESSMENT
CONCUSSION ASSESSMENT
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Tailored design – there is no current off-the-shelf solution
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Complex analysis of over 400,000 data points
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4 years development of proprietary Artificial Intelligence model
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7 international patents
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8 clinical trials in US, Australia and New Zealand
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Applicable to existing insurance charge codes
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Multiple FDA clearances
“There is no such thing as a good concussion – we need to manage each concussion seriously.”
Dr Adrian Cohen
Founder & CIO
About Headsafe Australia
An Australian start-up company, Headsafe has grown to over a dozen staff including research and development, data analysis, mechanical and electrical engineering and quality/regulatory personnel in just a few short years, won numerous product and design awards and become a vital part of the concussion dialogue.
The Nurochek device is a portable headset, with a front visor section which stimulates the retina with light and a rear section that measures the electrical response of the brain using unique electrodes. The software embodies a patented machine learning algorithm (AI) to classify readings and stored them securely in a dedicated cloud server.
The Nurochek product will be launched in the US healthcare market initially and was therefore developed under the exacting FDA regulatory framework based on data collection via large, multi-centre clinical trials and a rigorous medical quality framework to the international ISO13485 standard. Headsafe has worked with the FDA since 2019, gaining a first device clearance in 2020 and were cleared as aid for diagnosing concussion in 2023 and cleared in 2025 for the Nurochek Pro model.
FAQs
What is Nurochek?
Nurochek is a new FDA cleared medical device for assessing brain function and as an aid to the diagnosis of concussion.
What is the Nurochek Headset?
The device is a headset which goes over the eyes and the back of the head like a set of VR goggles or a ski/diving mask. An adjustable strap makes it comfortable for the two-minute test.
How does Nurochek work
Nurochek stimulates the eyes with a 30 second flashing light sequence and the specialised senses on the back of the headset pick up the brains resulting electrical activity (an EEG or electroencephalograph). This process is called Visual Evoked Potentials (VEP) and the resulting data is analysed by sophisticated artificial intelligence (AI) program cleared by the FDA as an aid to diagnosis by a treating doctor.
Does Nurochek hurt?
Not in the slightest!
How long does a Nurochek test take?
The entire test takes around 2 minutes.
Are there any people who are not suitable for Nurochek?
Your check is not suitable at the present time for anyone with a history of seizure disorder, epilepsy or previous structural brain injury.
How is Nurochek data analysed?
Results are analysed through a sophisticated machine learning (ML) Artificial Intelligence (AI) algorithm and are graphically displayed on a PC App from a secure, online server.
Do I need to have a baseline reading at the beginning of the season?
Because of the Ai process, a previous reading (or Baseline) is not required. Assessments can be made after an injury (in sports, a fall, motor vehicle accident etc) even if never assessed previously with Nurochek.
What is the research behind Nurochek?
Research in the US, Australia and New Zealand is ongoing to assess the utility of Nurochek as a point-of-care diagnostic aid for doctors in sports, EMS and hospital applications.
What regulatory approvals does Nurochek have?
Nurochek has three FDA clearances (USA) where it is recognised as an aid to the diagnosis of concussion in the hands of a licensed healthcare professional did neurological assessment. Nurochek is also registered with Medsafe WAND for use in New Zealand. At present, the device is approved for ethically overseen research in Australia and regulatory approval from the TGA is anticipated for early 2026 year.
Who can test me using Nurochek?
Nurochek is a prescription product for use by licensed healthcare professionals, and in research by qualified and appropriately trained personnel.
What is the science behind Nurochek?
Lots of work has been published on VEPs and on other Event Related Potentials (ERPs) which are electrical information from neural systems such as motor system (evoked through TMS Transcranial Magnetic Stimulation), the Visual-Ocular pathways, Acoustic pathways etc. These ERPs are all affected in concussion, because of the fact that individual nerves going to these different “systems” are all the same. Nurochek measures this electrical activity and determines if it is normal or abnormal.
Who decides when I can return to playing sport, or to go back to school or work?
Your doctor always makes these decisions about your health: Nurochek is designed as an aide to help the diagnosis.
