Aussie manufacturer ships locally made concussion diagnostic tool to US

Australian MedTech manufacturer Headsafe has commercialised a portable brain injury assessment device called Nurochek, designed to provide faster diagnosis of potential concussions.

Backed by co-investment from the Advanced Manufacturing Growth Centre, this home-grown technology is now FDA-cleared and available in the United States, with plans for expansion into further markets.

According to Headsafe, the project has enabled it to establish local manufacturing capabilities, double its R&D expenditure, and generate substantial export sales.

As a result, the company will employ 17 new staff and is expected to generate $84 million in revenues over the next five years.

Nurochek, dubbed as a ‘brain scanner in a briefcase,’ is claimed as a world-first device that can be deployed in mobile and clinical settings for rapid assessment and response to head injuries.

Verified extensively in the US and Australia, the FDA-cleared portable headset uses patented technology to measure the brain’s electrical activity, sending results to an online AI algorithm for analysis and secure storage in the cloud.

“Nurochek aims to take the uncertainty out of head injury diagnosis, all in the service of better patient outcomes,” said Dr Adrian Cohen, CEO and founder of Headsafe.

“Speed and accuracy of concussion diagnosis are key to better patient outcomes. Far too often head injuries are left undiagnosed or untreated because of delays in attaining a diagnosis or guesswork in the field – be it a sporting, motor vehicle, or other injury.”

Nurochek’s applications offer assessments for traumatic brain injuries from falls, motor vehicle accidents, military incidents, and potentially early-stage diagnosis of other acute and chronic brain conditions.

The two-year project involved 11 collaborative partners, helping Headsafe adapt the technology for field deployment and improve the product’s data processing, usability, and cloud analysis capabilities.

“Support from the Advanced Manufacturing Growth Centre and our collaborative partners has been instrumental in translating a clinical technology into an in-field solution with export potential,” added Dr Cohen.

“This project means that this world-leading product, its home-grown IP, and our ability to manufacture it remains onshore in Australia.”

Following FDA clearance, Headsafe will begin exporting Nurochek to the United States and is working towards certification in Australia, New Zealand, South Africa, and the European Union.

“Headsafe’s product epitomises the potential of Australian MedTech manufacturing,” said Dr Jens Goennemann, managing director of AMGC.

“Rather than taking Australian ideas offshore, Headsafe has created a local ecosystem that generates jobs and prosperity while attracting investment and customers from abroad. Being globally competitive is the sweet spot for Australian manufacturing.”

The Headsafe project was supported by GPC Electronics, Blue Quality Studios, Blackwattle IP, Western Sydney University, RQM+, Wearable Sensing, CLC consulting, Access Pointe, and international collaborators at the Icahn School of Medicine at Mount Sinai.