NUROCHEK
Introducing Nurochek, an FDA-cleared medical device that provides an objective concussion assessment in just 2 minutes.
Designed to standardise evaluations across healthcare facilities for the aid in diagnosis of concussion (mild traumatic brain injury or mTBI).
Years of development
International patents
Clinical trials in US, Australia and New Zealand
thousand data points per test
Innovative concussion assessment with AI proprietary technology, all in a single headset.
Tailored design – there is no current off-the-shelf solution
Fast results in just 2 minutes
Complex analysis of over 400,000 data points per test
Proprietary AI technology
10,000 EEG features distilled to 26
14 applicable CPT charge codes
Multiple FDA clearances
Winner of two Good Design awards
Secure cloud data storage
The Nurochek headset is designed to capture the electrical responses of the brain to visual stimuli. Our sophisticated AI model meticulously classifies these responses on a secure cloud server before transmitting the results to Windows computer.
Leading the race in concussion assessment
| Nurochek | Market Leader | |
|---|---|---|
| Type | EEG with AI | Neurocognitive Test |
| Single Test | 2 minutes | 20 minutes |
| Approach | Headset & iOS App | Desktop/Laptop/iOS device |
| Ease of use | High | Low |
| Objective | Yes | No |
| Baseline-free | Yes | No |
| Cost | $ | $ |
| FDA-cleared for concussion |  |
|
The Nurochek System is intended for prescription use in healthcare facilities for subjects aged between 16 and 46 years old, for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment (FDA-cleared on 27 December 2023).
From formal incorporation in 2017, significant progress has been made.
Feb 2017
HeadsafeIP Incorporated
Apr 2017
Clinical Advisory Panel appointed
May 2017
Slingshot HCF Catalyst Accelerator program
Jul 2017
Global Bridging Grant, Jobs4NSW MVP Grant
Aug 2017
Board constituted
Jan 2018
ISO13485 prototype
April 2018
Jobs4NSW Building Partnerships Grant
May 2018
Research prototype
Nov 2018
$175,000 in Australian Government funding
Feb 2019
Accepted to TMCx (Texas Medical Center Accelerator)
Mar 2019
Initial FDA Clearance
Dec 2021
Second FDA submission
Dec 2023
FDA clearance as Aid to Diagnosis
FAQs
Nurochek is a new FDA cleared medical device for assessing brain function and as an aid to the diagnosis of concussion.
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.
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.
Not in the slightest!
The entire test takes around 2 minutes.
Your check is not suitable at the present time for anyone with a history of seizure disorder, epilepsy or previous structural brain injury.
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.
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.
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.
Nurochek has two 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. At present, the device is approved for ethically overseen research in Australia and regulatory approval from the TGA is anticipated for later this year. Approvals in New Zealand and South Africa are also pending.
Nurochek is a prescription product for use by licensed healthcare professionals, and in research by qualified and appropriately trained personnel.
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.
Your doctor always makes these decisions about your health: Nurochek is designed as an aide to help the diagnosis.
Saving brains creates lasting value.
Discover how we’re leading the charge in concussion assessment.
