A game changer in concussion assessment
Nurochek is an FDA-cleared medical device that provides an objective concussion assessment in just 2 minutes.
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).
Fast
Objective
Affordable
Baseline-free
Easy to use
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 a PC.
Revolutionising concussion assessment with cutting-edge classification technology.
Compact concussion assessment that is easy to use, fast, and doesn’t require a baseline.
Our FDA-cleared Machine Learning (AI) classification is completely objective.
A fast test that can be performed by any healthcare professional with minimal training.
Insurers pay the doctor for approved tests (~2.3 assessments per concussion episode).
About Headsafe
We are a dynamic Australian medtech company that has developed a 2 minute portable brain assessment based on EEG to aid the diagnosis of concussion.
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.
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.
