Headsafe Enters U.S. Healthcare Market with FDA-Cleared Concussion Assessment Device
Lightweight portable system delivers fast, precise, objective data for rapid concussion diagnosis in emergency and clinical care settings
Headsafe, an emerging Australian medical technology company, today announced its strategic entry into the U.S. healthcare market with the launch of Nurochek™—a lightweight, portable, FDA-cleared brain assessment system engineered to enhance concussion evaluation in clinical settings through proprietary AI and machine learning (LLM) technology.
Headsafe is pleased to also confirm the appointment of Craig Corrance as Chief Executive Officer and Board Member. Corrance, a veteran MedTech executive, will lead U.S. commercialization, expand clinical partnerships, and support adoption across emergency departments, urgent care centers, neurology practices, and concussion clinics.
Nurochek™ is a portable, baseline-free EEG system that delivers objective brain function data in approximately two minutes using visual evoked potentials (VEPs), resulting in a precise EEG analyzed response triggered by light stimulus. Four hundred thousand data points are rapidly generated and analyzed via the supportive AI software resulting in a clear objective result. The Nurochek™ device is specifically engineered for healthcare environments where concussion decisions must be made swiftly and under intense time pressure, often with only limited objective data available.
Nurochek™ is FDA-cleared as a precise aid in the diagnosis of concussion (mTBI) for individuals aged 12 to 44 who have sustained a head injury within the past 120 hours (5 days), designed for use in conjunction with a standard professional neurological assessment.
"Frontline clinicians are asked to make concussion decisions quickly and often without complete patient related information. Nurochek™ adds precise objective brain function data analysis to support clinical diagnosis in healthcare settings, resulting in a significant increase in the accuracy of concussion diagnosis."
— Craig Corrance, CEO of Headsafe
"In Australia, we observed this challenge from the sidelines. When athletes sustain a potential head injury and leave the field or court, trainers, coaches, staff, and parents require immediate answers. There is simply no time for elaborate testing. Nurochek™ is designed for precisely such moments—whether on the sidelines or in a clinical setting. A trained healthcare professional places the headset, the intuitive software guides a brief, automated assessment, and within approximately two minutes, our proprietary AI-assisted system has analyzed over 400,000 brain-response data points. This elegant simplicity enables objective information to be delivered in real time across emergency departments, urgent care facilities, concussion clinics, and accredited training environments. It is unequivocally objective: you are concussed, or you are not—a game-changing support in the diagnostic process."
— Philip Gower, Chief Strategy and Commercial Officer
Headsafe's U.S. launch strategy emphasizes seamless real-world adoption by prioritizing practical implementation, comprehensive training, and simple integration into established clinical workflows. Initial efforts are focused on high-volume concussion management settings, including emergency medicine, urgent care, neurology, sports medicine, and certified athletic trainers (ATCs).
Information Requests
Clinicians and healthcare organizations can request additional information via www.headsafe.com or by emailing info@headsafe.com.
Media Resources
Product brochure, images, and additional information are available upon request.
About Headsafe
Headsafe is a MedTech company headquartered in Sydney, Australia, with a growing U.S. presence. Its mission is to make concussion assessment faster, safer, and more consistent across points of care.
The company's flagship product, Nurochek™, is a portable, FDA-cleared brain assessment device that delivers objective brain function data in approximately two minutes, without requiring a baseline test. Designed for use in emergency departments, urgent care, neurology clinics, and sports medicine settings, Nurochek™ is intended for use in healthcare facilities.
With U.S. and Global Operations led by CEO Craig Corrance, Headsafe is focused on supporting real-world adoption through practical implementation, training, and clinical workflow integration.
Important Use Information
Nurochek™ is FDA-cleared as an aid in the diagnosis of mild traumatic brain injury (mTBI, concussion) when used in conjunction with a standard neurological assessment. It is cleared for individuals ages 12 to 44 years old, within 120 hours (5 days) of a potential head injury, and is intended for prescription use in healthcare facilities or by healthcare professionals. Exclusion criteria apply, including seizure history, epilepsy, certain structural brain injuries, and legal blindness.