RightEye Vision System

by RightEye  · Based in United States →Revolutionizing healthcare with advanced eye-tracking technology.
Neurology Ophthalmology Physical Medicine & Rehab

Initial setup fee $10,000-$15,000; annual fee $2,500-$5,000 (as of 2019).
Regulatory Status Disclosed

Overview

The RightEye Vision System is a portable, non-invasive eye-tracking system designed to objectively measure and analyze eye movements with high precision. Utilizing high-speed cameras and sophisticated software, it captures thousands of data points per second to provide detailed insights into visual function and neurological health. The system generates easy-to-understand, objective reports that help healthcare providers identify abnormalities or irregularities in eye movement, fixation, and response to visual stimuli. It offers customizable testing protocols and a cloud-based platform for managing patient data and tracking progress over time. The RightEye Dynamic Vision Trainer™ also provides online oculomotor training programs to help improve identified impairments.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • High-speed eye-tracking cameras
  • Advanced software analysis
  • Objective, quantitative data and reports
  • 5-minute, non-invasive assessments
  • Real-time results and comprehensive reports
  • Customizable testing protocols
  • Cloud-based software platform
  • EyeQ Trainer for oculomotor training
  • Measures various eye movements (saccades, smooth pursuits, fixation)
  • Compares patient results to age-based reference data

Use Cases

  • Diagnosing functional vision problems
  • Concussion and Traumatic Brain Injury (TBI) assessment
  • Identifying reading and learning difficulties
  • Sports vision training and performance optimization
  • Neurological screening (e.g., Parkinson's disease, with FDA warning regarding off-label promotion)
  • Vision therapy and rehabilitation

What Physicians Need to Know

Neurodegenerative Disease Screening
The RightEye Vision System has received FDA Breakthrough Device Designation for its eye movement-tracking system as a test for Parkinson's disease, aiming to aid in earlier detection by identifying ocular tremors. It can also identify specific eye movement patterns associated with other neurodegenerative conditions like Alzheimer's disease, assisting in early detection and monitoring disease progression.
Concussion / Traumatic Brain Injury (TBI) Detection
The system can detect and measure the severity of concussions and traumatic brain injuries (TBIs) by tracking subtle changes in eye movement, coordination, and reaction times. It provides objective data to monitor recovery progress and support rehabilitation.
Functional Vision Assessment
RightEye diagnoses functional vision problems that can affect reading, learning, and sports performance by analyzing eye movements, visual alignment, reaction time, and tracking speed. It can identify issues like tracking difficulties, involuntary eye movements, and fixation losses.
Automated Sensorimotor Exam
RightEye offers the world's first automated, quantitative sensorimotor exam system to objectively identify and quickly address binocular vision issues and oculomotor dysfunction. A basic screening can be done in under 30 seconds, with a comprehensive exam taking a few minutes if needed.
AI / Machine Learning
The cloud-based RightEye Vision System utilizes artificial intelligence (AI) and machine learning to track eye movements, analyze patterns, and deliver normative scores based on extensive data.
Assessment Speed
Assessments are quick and non-invasive, typically taking 5-7 minutes for a comprehensive evaluation. Automated sensorimotor screenings can be completed in less than 30 seconds.
Objective Data & Reporting
The system provides objective, quantifiable data on eye movements and visual function, eliminating guesswork in diagnosis. Detailed, easy-to-read EyeQ reports are generated, translating metrics into actionable insights.
Physician Tip

RightEye provides objective, non-invasive, and rapid assessments of eye movements, serving as valuable biomarkers for various neurological and functional vision issues. It is particularly beneficial for early detection and monitoring the progression of neurodegenerative diseases like Parkinson's, and for assessing concussions/TBIs. The system can help differentiate functional vision problems from other cognitive or learning disorders, complementing traditional neurological and ophthalmological exams by providing quantifiable data on visual function and brain health. The automated sensorimotor exam offers an efficient way to identify binocular vision issues and oculomotor dysfunction.

The RightEye Vision System is a cloud-based platform leveraging AI and machine learning for eye movement analysis and normative scoring. It generates comprehensive, data-rich reports (EyeQ reports) that are designed to be easy to interpret. The hardware and software solution is built for seamless integration into existing clinical workflows, and it can recommend computer-based exercises for personalized vision therapy programs.

Details

Category Neurology AI, Ophthalmology AI
Pricing Initial setup fee $10,000-$15,000; annual fee $2,500-$5,000 (as of 2019). Initial: $10k-$15k; Annual: $2.5k-$5k (2019 data)
DeploymentOn-premise hardware (Tobii Dynavox i15) with cloud-based software, runs on Windows 10.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The RightEye Vision System received FDA 510(k) clearance (K181771) on September 28, 2018, as a Class II Nystagmograph medical device for recording, viewing, and analyzing eye movements to identify visual tracking impairment in human subjects. In January 2023, the FDA issued a Warning Letter citing misbranding due to promotion beyond its cleared indications and failure to conform with good manufacturing practice requirements.

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

What the Web Says

The RightEye Vision System is an FDA-cleared, non-invasive eye-tracking technology that objectively measures and analyzes eye movements to identify visual tracking impairments and functional vision problems. It's used by healthcare providers to assess brain health, concussions, reading disorders, and athletic performance. The system provides detailed, objective data that traditional eye exams often miss, helping doctors make more informed diagnostic and treatment decisions.

Overall: Mixed

Strengths

  • Provides objective, quantifiable data on eye movements and visual processing, which standard eye charts cannot.
  • Can help diagnose functional vision problems, concussions, and neurological disorders like Parkinson's disease earlier.
  • Testing is quick (around 5 minutes), non-invasive, and comfortable for most patients, including children.
  • Generates immediate, easy-to-understand visual reports for doctors and patients.
  • Useful for tracking progress in vision therapy and rehabilitation programs.
  • Can be used to improve sports performance by analyzing reaction time, brain processing, and eye movements.

Limitations

  • The FDA issued a warning to RightEye in 2023 for promoting the device beyond its cleared indications for use, specifically for improving vision problems and diagnosing neurological disorders like Parkinson's, without proper clearance.
  • Some Reddit users discuss ongoing vision issues even after using similar systems or undergoing vision therapy, suggesting it may not be a complete solution for all.
  • Limited reviews available on platforms like G2 and Capterra, and only two reviews on Trustpilot with an average score.

Based on reviews from: Reddit, Neuro-Visual Performance Institute, Glance by Eyes On Eyecare, VA Research - Veterans Affairs, Review of Optometry, Healio, BioSpace, Advanced Eyecare & Therapies, Trustpilot, Functional Vision Problems, Advanced EyeCare, Brain Health D.C., 20/20 Magazine, PR Newswire, FDA, RightSPINE Chiropractic Neurology

Last updated: 2026-07-19

Ratings & Reviews

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Press & Coverage

NeurologyLive
FDA Grants Breakthrough Designation for RightEye Vision System, Results from ESETT Trial Released, Conference Coverage of the 73rd Annual Meeting of the American Epilepsy Society
The FDA granted Breakthrough Device Designation to the RightEye Vision System, an eye-tracking technology being evaluated for diagnosing Parkinson's disease. This designation aims to streamline the development and review process for devices that offer more effective diagnosis or treatment for life-threatening or debilitating conditions.
2019-12
BioWorld
Righteye wins breakthrough device designation for Parkinson's test
RightEye LLC's eye movement-tracking vision system received breakthrough device designation from the U.S. FDA as a test for Parkinson's disease. The cloud-based system uses AI and machine learning to track eye movements and provide a normative score, potentially aiding in earlier detection of the disease.
2019-12
PR Newswire
RightEye Vision System Receives Breakthrough Device Designation from U.S. FDA for Parkinson's Disease Test
RightEye LLC announced that its RightEye Vision System received Breakthrough Device Designation from the FDA for its use in assessing Parkinson's disease. This designation is given to medical devices that offer more effective diagnosis or treatment for life-threatening or irreversibly debilitating conditions.
2019-12
Glance by Eyes On Eyecare
FDA warns RightEye of violations with vision system
The FDA issued a Warning Letter to RightEye, LLC, in January 2023, citing misbranding and adulteration of its RightEye Vision System. The violations included promoting the device for uses beyond its cleared indications, such as diagnosing ADHD, mTBI, or Parkinson's disease.
2023-02
Ophthalmology Times
FDA Issues Warning Letter to RightEye for Misbranding and Adulteration of Its Vision System
In February 2023, the FDA issued a Warning Letter to RightEye, LLC, for misbranding and adulteration of the RightEye Vision System. The letter detailed violations including promotion of the device for uncleared indications and failure to conform with good manufacturing practice requirements.
2023-02
FDA
RightEye, LLC - 643192 - 12/20/2022
The FDA issued a Warning Letter to RightEye, LLC, on December 20, 2022, detailing violations related to the misbranding and adulteration of the RightEye Vision System. The letter specifically cited the firm's promotion of the device for indications beyond its cleared use, such as improving vision problems and assessing neurological disorders like Parkinson's disease.
2023-01
Sheppard Mullin
FDA Issues Warning Letter to RightEye, LLC For Misbranding and Adulteration
A legal analysis of the FDA's Warning Letter to RightEye, LLC, highlights misbranding due to promotion beyond cleared indications and adulteration for failing to meet manufacturing practice requirements. The FDA found that RightEye promoted its Vision System for neurological disorders like ADHD, mTBI, and Parkinson's disease without the necessary clearances.
2023-02
MDPI
Age- and Sex-Based Developmental Biomarkers in Eye Movements
This peer-reviewed article, published in December 2024, discusses a study that used the RightEye Vision System to identify age- and sex-based developmental biomarkers in eye movements. The research involved participants from optometry practices across the United States and focused on six eye movement assessments.
2024-12

Videos

Product demos, reviews, and walkthroughs for RightEye Vision System.

View all on YouTube

Frequently Asked Questions

The RightEye Vision System employs advanced eye-tracking technology and proprietary software algorithms to analyze eye movement data, providing objective measurements that are often imperceptible to the naked eye. This AI-driven analysis helps identify visual tracking impairments, oculomotor dysfunctions, and can be applied to functional vision screening, reading assessments, sports vision, and brain health evaluations.
The RightEye Vision System received FDA 510(k) clearance in 2018 for recording, viewing, and analyzing eye movements to identify visual tracking impairment, and a Breakthrough Device Designation in 2019 for aiding in Parkinson's disease evaluation. However, the FDA issued a Warning Letter in January 2023, citing misbranding and adulteration due to the company promoting the device for uncleared indications, such as diagnosing ADHD, mTBI, or Parkinson's, or 'improving vision problems,' which carries risks of misdiagnosis or delayed treatment.
RightEye states that it encrypts all personal health information data transferred and stored remotely on its web server. The system also utilizes non-personally identifiable information (Non-PII) for service improvement and analysis, indicating measures to protect patient privacy.
A significant limitation is that the RightEye Vision System is cleared for identifying visual tracking impairment, not for diagnosing specific neurological conditions like ADHD, mTBI, or Parkinson's disease, nor for 'improving vision problems' as a treatment. The FDA has warned that using the device for these uncleared indications could lead to misdiagnosis, delayed appropriate treatment, and potentially serious secondary injuries.
The RightEye Vision System is designed as a portable, non-invasive, and easy-to-use eye-tracking system that can be integrated into various healthcare settings. Testing typically takes only a few minutes, with patients comfortably following visual prompts on a screen, and generates immediate, objective reports to aid clinical decision-making.
While direct competitors for eye-tracking diagnostic systems like VividVision exist, other AI-driven solutions in eyecare focus on different aspects, such as Digital Diagnostics for diabetic retinopathy or CSI Dry Eye Software for dry eye disease. RightEye's AI-driven approach offers objective, quantitative measurements of eye movements, which can provide insights not attainable through traditional observational exams, enhancing the efficacy of identifying visual tracking impairments.
Specific pricing details for the RightEye Vision System for medical practices are not publicly disclosed in the search results. However, the extended sensorimotor exam offered by RightEye is noted as being medically billable and eligible for insurance reimbursement, which can provide a revenue opportunity for practitioners.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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