EYE-SYNC

by NeuroSync (formerly SyncThink)  · Based in United States → — The New Brain Health Vital Sign
Neurology Physical Medicine & Rehab Sports Medicine

Regulatory Status Disclosed

Overview

EYE-SYNC is a groundbreaking, proprietary eye-tracking technology developed by NeuroSync (formerly SyncThink). It is an FDA-cleared, AI-powered virtual reality (VR) based digital health platform designed for medical professionals to objectively measure brain health and performance. The system utilizes patented algorithms and analytics to assess brain function in real-time by analyzing eye movements, identifying visual tracking impairment, and measuring synchronization abilities.

The platform provides rapid, objective assessments, often completed in under 60 seconds, generating customizable and interpretive reports. These reports offer detailed metrics, symptoms, and visuals describing a patient’s performance, including the type and severity of dysfunction identified. EYE-SYNC supports clinical decision-making, aids in monitoring recovery, and offers visual and vestibular therapies to address deficits and optimize brain performance.

Initially cleared by the FDA in 2016 for identifying visual tracking impairment, EYE-SYNC received Breakthrough Device Designation in 2019 and a second FDA clearance in October 2021 as an aid to concussion (mild Traumatic Brain Injury) diagnosis.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Objective eye-tracking assessments
  • Virtual Reality (VR) headset platform
  • AI and patented algorithms for analysis
  • Rapid assessment (under 60 seconds)
  • Cloud-connected analytics
  • Mobile and wireless deployment
  • Customizable and interpretive reports
  • Supports visual and vestibular therapies
  • Objective data for clinical decision making
  • Training tools to improve performance

Use Cases

  • Concussion and mild Traumatic Brain Injury (mTBI) diagnosis and assessment
  • Monitoring recovery from brain injury
  • Rehabilitation of ocular-motor and ocular-vestibular deficits
  • Optimizing brain performance and dynamic vision
  • Screening for neurological impairment (e.g., fatigue, sleep deprivation)
  • Athlete readiness assessment and injury prevention

What Physicians Need to Know

Neurodegenerative Disease Screening
EYE-SYNC technology claims to detect conditions such as ADHD, concussion, Parkinson's disease, and other neurodegenerative disorders by measuring specific variance of synchronization abilities, acting as a biomarker of impairment or pathology.
Triage Prioritization Speed
EYE-SYNC assessments are rapid, completing in less than 60 seconds, which facilitates quick screening and identification. It provides actionable, objective data in under a minute, aiding in rapid quantification of readiness and optimizing performance.
Mobile Notification System
The system's AI automatically analyzes test results and sends a report to a connected Android tablet to assist physicians with diagnosis. The platform is cloud-connected and HIPAA-compliant, supporting data exchange and control via a mobile tablet.
Physician Tip

EYE-SYNC is an FDA-cleared, VR-based eye-tracking tool that offers objective and rapid (under 60 seconds) assessments of ocular-motor function. It is primarily used as an aid in concussion diagnosis and for identifying visual tracking impairments. The platform also supports screening for neurodegenerative disorders like Parkinson's disease and dementia, as well as ADHD. Clinicians receive detailed, interactive reports with metrics and visuals, and the system can track recovery and treatment effectiveness. While a baseline can be beneficial, it is not strictly required for assessment.

The EYE-SYNC platform is a cloud-connected, HIPAA-compliant digital health solution delivered via a wireless Virtual Reality (VR) goggle platform, typically paired with an Android tablet for control and data management. It features proprietary software and analytics, with customizable features and integration capabilities. SyncThink has partnered with companies like PicoXR and Magic Leap, indicating compatibility with various XR hardware and a focus on expanding healthcare applications.

Details

Category Neurology AI, Ophthalmology AI
Pricing Unknown
DeploymentVR headset with tablet, cloud-based platform
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

EYE-SYNC received initial FDA clearance in March 2016 (K152915) for recording, viewing, and analyzing eye movements to identify visual tracking impairment. It was granted FDA Breakthrough Device Designation in February 2019 and a second FDA clearance in October 2021 (K202927) as an aid to concussion (mild Traumatic Brain Injury) diagnosis.

Integrations
EHR Not specified
Specialties Neurology, Physical Medicine & Rehab, Sports Medicine

What the Web Says

EYE-SYNC is a medical device designed to objectively assess brain health and detect concussions using eye-tracking technology. Reviews from physicians generally highlight its potential for objective assessment and quick results, while tech reviewers appreciate the innovative application of eye-gaze tracking. However, some sources raise concerns about its current limitations and cost.

Overall: Mixed

Strengths

  • Objective and quantifiable assessment of brain function
  • Rapid results (minutes) for quick sideline or clinic evaluation
  • Non-invasive and easy to administer
  • Potential to reduce subjective bias in concussion diagnosis
  • FDA-cleared, adding credibility for medical use
  • Portable and can be used in various settings

Limitations

  • Cost can be a barrier for smaller clinics or individual practitioners
  • Requires specialized training to operate effectively
  • May not be a standalone diagnostic tool, often used in conjunction with other assessments
  • Limited long-term data on its impact on patient outcomes compared to traditional methods
  • Some users report a learning curve for both administrators and patients
  • Potential for false positives/negatives if not used correctly or in appropriate contexts

Based on reviews from: Physician reviews (various medical forums and publications), Healthcare IT publications, Tech review sites (e.g., Engadget, The Verge - for similar tech applications), Reddit (discussions on medical devices and concussion), G2 (for medical device or diagnostic tool reviews - if available for similar products), Capterra (less likely for medical devices, but checked for general health tech)

Last updated: 2026-07-20

Ratings & Reviews

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Press & Coverage

RAPS
FDA warns four device makers over lax processes - RAPS
NeuroSync received a warning letter from the FDA on May 9, 2025, citing cGMP violations related to design control procedures for its EYE-SYNC device, a virtual reality headset and tablet used for assessing eye movements. The FDA concluded that the company failed to establish and maintain procedures to control device design and ensure specified requirements were met, such as the accuracy of eye tracking performance test results.
2025-05
Dr. Sarah Cheyette, MD (Blog)
Eye Tracking for ADHD and Concussions - Dr. Sarah Cheyette, MD
Dr. Sarah Cheyette discusses her use of NeuroSync's EYE-SYNC system in her Bay Area clinic to objectively measure attention and aid in concussion diagnosis and management. She highlights its FDA clearance as an assessment battery for eye movement analysis in concussion diagnosis and its ability to track recovery.
2025-04
Preprints.org
Identifying Pertinent Digital Health Topics to Incorporate into Self-Care Pharmacy Education
This study, published as a preprint, identifies pertinent digital health devices and applications for self-care pharmacy education, including EYE-SYNC. It notes EYE-SYNC's FDA clearances in 2016 for visual impairment identification, 2019 as a Breakthrough Device Designation for concussion assessment, and 2021 as an aid in concussion diagnosis.
2024-06
NeuroSync (Press Release)
XFL and NeuroSync Announce Partnership to Advance Concussion Protocol
The XFL and NeuroSync announced a partnership making EYE-SYNC the Official and Exclusive Concussion Management Technology of the XFL. The technology provides objective data to support concussion diagnostic decision-making and ensure a safe return to play for athletes.
2023-05
NeuroSync (Press Release)
SyncThink Rebrands as NeuroSync, Eyes Neurological Healthcare Market Growth
SyncThink announced its rebranding to NeuroSync in September 2022, aiming to accelerate its presence in the broader neurological healthcare market. The company plans to leverage EYE-SYNC's core technology, intellectual property, and clinical data to deliver diagnostic and therapeutic solutions.
2022-09
NeuroSync (Press Release)
SyncThink Secures CE Mark for EYE-SYNC Digital Health Platform
SyncThink announced in August 2022 that its EYE-SYNC technology received CE Mark certification, affirming conformity to European Medical Device Regulation (MDR). This certification allows for the commercialization of EYE-SYNC in the European Union and the United Kingdom.
2022-08
NeuroSync (Press Release)
SyncThink Receives Second FDA Clearance for EYE-SYNC Platform; the First Mobile, Rapid Test for Concussion
In October 2021, SyncThink announced that the FDA granted its second clearance for EYE-SYNC as an Aid to Concussion, or mild Traumatic Brain Injury (mTBI) Diagnosis. This clearance followed its Breakthrough Device Designation in 2019 and initial commercialization in 2017.
2021-10
NCBI Bookshelf (Medical Journal/Report)
An Overview of Clinical Applications of Virtual and Augmented Reality - NCBI Bookshelf
This overview of clinical applications of VR and AR in healthcare mentions EYE-SYNC as a VR system using eye tracking that received FDA clearance in 2021 to aid in concussion diagnosis. It notes that EYE-SYNC assesses a patient's ability to synchronize eye movement with a moving object and gaze fixation.
2021-10

Videos

Product demos, reviews, and walkthroughs for EYE-SYNC.

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Frequently Asked Questions

EYE-SYNC utilizes a modified virtual reality headset and a connected tablet to perform 60-second eye-tracking assessments, providing objective data on visual impairments, ocular-motor, and ocular-vestibular deficits. This rapid assessment tool aids clinicians in evaluating brain function, monitoring recovery, and supporting rehabilitation, offering immediate, detailed reports to inform diagnosis and treatment plans.
EYE-SYNC is FDA-cleared as an aid to concussion/mild traumatic brain injury diagnosis for patients 17-24 years of age, and for recording and analyzing eye movements to identify visual tracking impairment. It also holds CE Mark certification, affirming conformity to European Medical Device Regulation (MDR) as a Class I medical device, and ensures patient data privacy through HIPAA-compliant cloud connectivity.
Unlike subjective symptom reporting or traditional neurological tests that can be prone to bias or require baseline data, EYE-SYNC provides objective, quantifiable measurements of eye movements. While it is an advanced tool, it is intended to be used in conjunction with a standard neurological assessment rather than as a standalone diagnostic.
While specific pricing details are not publicly available in the provided information, EYE-SYNC is described as cost-effective with various economic solutions for acquisition. The platform emphasizes an 'unlimited use' model, indicating no per-test fees once the system is acquired.
EYE-SYNC is an aid to diagnosis and should be used in conjunction with a comprehensive neurological assessment, not as a sole diagnostic tool. Its accuracy can be influenced by factors such as calibration errors, head movements, and patient cooperation, and its initial FDA clearance for concussion aid was specific to patients aged 17-24 years.
EYE-SYNC ensures patient data privacy and security through end-to-end encryption for all captured data, which is then stored in a HIPAA-compliant cloud. This secure infrastructure allows for the export of results via PDF or through secure data transfer via API, maintaining confidentiality while enabling data utilization.
EYE-SYNC's proprietary algorithms and deep learning models have been validated through over 15 years of clinical research, resulting in more than 30 published peer-reviewed papers and 15 granted patents. A clinical study involving over 1,600 subjects demonstrated sensitivity above 82% and specificity over 93% in detecting concussion, with the system designed to deliver results without bias from the patient or clinician.

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Suggest an Edit → | Last Verified: 2026-04-21 | First Added: 2026-04-21
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