Headsafe

What Headsafe does

Headsafe is an Australian-origin brain health technology company that has developed Nurochek, a portable EEG and Visual Evoked Potential (VEP) brain scanner positioned as the world's first FDA-cleared device of its kind for concussion assessment. The Nurochek-Pro System combines a lightweight, reusable, no-gel EEG headset with two software components, a locally installed Windows-based Data Collection Software and a cloud-hosted Diagnostic Software on AWS, to deliver an objective brain function assessment in approximately two minutes for patients aged 12-44 within 120 hours of potential head injury. Proprietary AI and machine-learning algorithms analyze over 400,000 data points per scan, comparing captured VEP/EEG signals against normative data to produce an objective aid-to-diagnosis result that does not require a pre-injury baseline. The technology is protected by 7 international patents and validated through multi-site studies in Australia, New Zealand, and the United States, with regulatory assets including FDA 510(k) clearance (K243426, March 2025), ISO 13485:2016 certification, and an MDSAP Certificate of Registration (May 2026).

Headsafe monetizes Nurochek through a hybrid hardware-plus-software model: hardware sales of the headset and accessories to licensed healthcare providers, plus non-exclusive software licensing of the Data Collection and Diagnostic Software, with multi-year subscription-style arrangements and purchase or lease options. Pricing is quote-based and not publicly disclosed, with contract structures subject to license fee adjustments on 45 days' notice. The go-to-market combines direct enterprise field sales with channel partnerships, including Spartan Medical (an SDVOSB-certified U.S. distributor providing access to VA, DoD, and civilian hospital channels) and MedTech Labs Group (authorized ANZ distributor). Target customer segments span emergency medicine, sports medicine (high school through professional), urgent care, and imaging centers, with U.S. commercialization actively underway following January 2026 market entry under a newly appointed CEO.

The corporate structure consists of parent Headsafe Holdings Pty Ltd (Australia), manufacturing entity Headsafe MFG Pty Ltd (Surry Hills, NSW), and U.S. commercial subsidiary Headsafe US, Inc. (Lake Mary, Florida). Leadership includes Founder and Chief Innovation Officer Dr. Adrian Cohen and CEO Craig Corrance, supported by a CXO team covering technology, commercial, and finance functions. The company is privately held with no disclosed institutional funding beyond a 2017 Sydney Angels seed round and a 2024 Pacific Channel investment, leaving ownership and capital structure as material data gaps for prospective investors.

Name

Headsafe

Legal name

Headsafe Group

Website

https://headsafe.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

1–10 employees

Short description

Headsafe is a medical device company that developed Nurochek, the first FDA-cleared portable EEG/VEP brain scanner delivering objective two-minute concussion assessment without baseline testing, sold to healthcare providers across emergency medicine, sports medicine, urgent care, and imaging centers.

Ownership category

akta.pro rank

Product category

Neurological Diagnostic Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Neurological Monitoring (EEG, Seizure/Sleep/Neuro Wearables) (HLAHACAE)

akta.pro secondary industry

Medical-Grade Device Connectivity & Device Management (MDM) (HLACAFAG)

Keywords

• Portable brain scanner
• Concussion assessment device
• Neurological diagnostic equipment
• EEG medical device
• Brain health technology

Headquarters

HQ city

Bronte

HQ country

Australia

HQ region

Oceania

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Supply Chain, Personnel, Marketing or Sales, Operations, Infrastructure

Revenue model

1. Hardware Sales: Sale of Nurochek Pro hardware device comprising SSVEP/EEG headset, sensors, cable and accessories. Hardware is sold to licensed healthcare providers with title passing upon delivery to carrier at Headsafe's US shipping point.
2. Software Licensing: Non-exclusive, non-transferable license for Data Collection Software (installed on client devices) and Diagnostic Software (cloud-based service). Access subject to License Fee payment. Headsafe provides technical support, maintenance, and updates included with license.
3. Lease/Rental Model: Products available through purchase or lease as indicated on website marketing materials. Supports flexible commercial arrangements for healthcare facilities.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels6 records

Core offering

Headsafe develops and sells the Nurochek-Pro System, the world's first FDA-cleared portable brain scanner for objective concussion assessment. The system combines a reusable, no-gel EEG headset with proprietary AI/ML software to deliver brain function data in approximately 2 minutes without requiring a pre-injury baseline. It is sold as a prescription medical device to licensed healthcare providers across emergency departments, sports medicine programs, urgent care centers, imaging facilities, neurology practices, and concussion clinics in the U.S., Australia, and New Zealand.

Product overview

Headsafe offers a unified medical device platform consisting of the Nurochek™-Pro System, which combines the Nurochek™ hardware headset with Nurochek™ Pro Software. The hardware is a lightweight, reusable EEG/VEP headset that captures brain signals, while the software comprises Data Collection Software (installed locally on Windows devices) and a cloud-hosted Diagnostic Software service that analyzes captured data. The system delivers objective concussion assessment in 2 minutes without requiring pre-injury baseline testing. All components are regulated under a single FDA 510(k) clearance (K243426) and are offered together as an integrated brain health assessment solution.

Differentiator

Problem solved

Functional benefit

Brands

• Nurochek™: World's first FDA-cleared portable brain scanner using EEG and Visual Evoked Potential (VEP) technology for objective concussion assessment in 2 minutes without baseline required. Protected by 7 international patents.

Products and services

• Nurochek-Pro System FDA-cleared (510(k) K243426) prescription medical device comprising a no-gel, reusable EEG headset hardware and the Nurochek Pro Software. It performs objective concussion/mTBI assessment in approximately 2 minutes using EEG and Visual Evoked Potential (VEP) signals analyzed by proprietary AI/ML algorithms, delivering results without requiring a pre-injury baseline. Intended for use on patients aged 12-44 within 120 hours of potential head injury as an aid in diagnosis of mild traumatic brain injury in conjunction with standard neurological assessment.

Quantifiable outcome

• 2-minute objective concussion assessment (vs traditional methods taking 10-30 minutes)
• +2 more outcomes

Named customers6 records

Segments4 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature4 records

Partnerships

Two partnerships are on record, tiered core.

• Spartan Medical, Inc.coreChannel Partner/ Reseller/ Distributor · 1 March 2026Headsafe partnered with Spartan Medical, a veteran-owned SDVOSB certified medical distribution company, to distribute Nurochek across U.S. healthcare settings. The partnership leverages Spartan Medical's established federal contracting credentials, national distribution infrastructure, and deep expertise in VA and DoD procurement channels. Founded in 2008 by Vince Proffitt, former Air Force Intelligence Officer, Spartan Medical holds over 700 federal contracts and serves as a 'top priority vendor' within the VA system with access to 30+ military treatment facilities.
• MedTech Labs GroupcoreChannel Partner/ Reseller/ DistributorMedTech Labs Group serves as the authorized distributor for Nurochek across Australia and New Zealand. The partnership provides comprehensive distribution, support, and market access for medical technology products throughout the ANZ region.

Scale indicators7 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• SyncThink: SyncThink develops FDA-cleared virtual reality-based eye-tracking technology (Eyesync) for concussion diagnosis and balance assessment. Directly comparable to Nurochek in providing objective, device-based concussion assessment for sports medicine and military use cases, with overlapping federal and professional sports customer base.
• ImPACT Applications: ImPACT Applications is the most widely deployed computerized concussion assessment tool in US sports medicine and clinical practice. Both companies target the same use cases (sideline assessment, return-to-play decisions) and compete for the same customer segments (athletic programs, sports medicine clinics, hospitals), though ImPACT relies on cognitive/neuropsychological testing while Headsafe uses EEG/VEP.
• BrainScope: BrainScope developed FDA-cleared EEG-based traumatic brain injury assessment devices for emergency and clinical use. BrainScope and Headsafe both target objective, EEG-based TBI assessment in ED and urgent care settings, making them direct competitors in the portable brain assessment category with overlapping regulatory pathways and customer bases.
• C3 Logix: C3 Logix provides multimodal concussion assessment combining cognitive testing, balance, and vestibular measures for sports and clinical use. Comparable to Nurochek in serving high school, collegiate, and professional sports programs with objective brain assessment data for return-to-play decisions.

Emerging players

• MindMaze: MindMaze develops digital neurotherapeutics and brain assessment platforms combining AI, VR, and biosensors for neurological recovery and assessment. Comparable in applying AI-driven analytics to brain function data for clinical and research applications, with adjacent positioning in concussion and TBI assessment workflows.
• Wave Neuroscience: Wave Neuroscience (formerly Wave Neuroscience/Electroencephalography-based Personalized Brain Stimulation) develops EEG-based assessments for brain injury and neurological conditions. Comparable in using proprietary EEG analytics for brain health assessment, though focused more on post-injury treatment than acute concussion triage.
• Emotiv: Emotiv produces consumer and research-grade EEG headsets with cloud analytics. Comparable in portable EEG hardware design and cloud-based signal processing, though primarily focused on consumer/research applications rather than FDA-cleared clinical concussion assessment.

Broad incumbents

• ANT Neuro: ANT Neuro is a long-established manufacturer of EEG systems and brain monitoring equipment used in clinical and research applications. Comparable in producing EEG hardware/software for brain function assessment, with overlapping research-grade and clinical-grade EEG capabilities, though ANT Neuro primarily serves research and hospital neurology rather than sideline concussion use cases.
• Ceribell: Ceribell offers FDA-cleared, portable EEG monitoring for seizure detection in hospital and emergency settings. While focused on continuous seizure monitoring rather than single-point concussion assessment, Ceribell overlaps in EEG hardware, cloud diagnostics, and the enterprise hospital channel where Nurochek is sold.

Regional players

• Compumedics Neuroscan: Compumedics is an Australian-headquartered manufacturer of EEG and sleep diagnostic systems with global distribution. Comparable as an EEG-based brain monitoring company headquartered in Australia with international sales infrastructure; while primarily focused on sleep and research EEG, it represents a regional incumbent in the same category.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/NeckSafe
• Facebookfacebook.com/necksafe

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries2 records

Funding overview

Funding rounds2 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Headsafe