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EyeBOX

by Oculogica · Based in United States → — Objective Concussion Diagnosis Without the Guesswork.

Emergency Medicine Neurology Sports Medicine

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Overview

EyeBOX by Oculogica is an innovative, FDA-cleared AI-powered eye-tracking device designed to objectively aid in the diagnosis of concussion (mild traumatic brain injury) and monitor recovery. Utilizing a proprietary algorithm and machine learning, the EyeBOX system tracks subtle eye movements, collecting over 100,000 data points in less than four minutes. This non-invasive test does not require a pre-injury baseline, making it highly valuable for immediate assessment in various clinical settings.

The device analyzes cranial nerve function by observing how eyes respond to visual stimuli, providing a ‘BOX score’ that correlates with the presence or absence of a concussion. Its baseline-free nature ensures that results cannot be influenced by patient will or literacy level, broadening its applicability across a wide patient range from 5 to 67 years of age. Recent FDA label expansions also allow for monitoring a patient’s recovery over time by comparing eye-tracking metrics against a normative population, supporting return-to-activity decisions and therapeutic interventions.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

AI-powered eye-tracking technology
Objective concussion diagnosis
Baseline-free assessment (no pre-injury data needed)
Non-invasive test
Rapid results (under 4 minutes)
Broad patient age range (5-67 years)
Proprietary algorithm and machine learning
Portable and lightweight device
Reimbursable (CPT code available)
Monitors concussion recovery over time

Use Cases

Diagnosing acute concussion in emergency settings
Monitoring patient recovery post-concussion
Informing return-to-play decisions in sports medicine
Assessing concussions in pediatric populations
Evaluating head injuries in urgent care clinics
Providing objective data for medico-legal cases

What Physicians Need to Know

Evidence Base

EyeBOX is FDA-cleared and Health Canada registered as a diagnostic aid for concussion. It is the subject of 16 peer-reviewed studies, with some sources citing 14 or multiple publications. The technology is based on the cranial nerve control of eye movements. A recent FDA label expansion (April 2025) permits clinicians to compare a patient's eye-tracking metrics against a normative population to assess recovery, therapy, and guide return-to-activity decisions.

Clinical Validation Studies

EyeBOX has been the subject of multiple peer-reviewed studies. A pivotal clinical study for FDA clearance included 282 patients (ages 5-67) assessed within two weeks of injury, demonstrating a sensitivity of 80.4% and a specificity of 66.1% for concussion diagnosis. A study published in *Military Medicine* (August 2024) indicated EyeBOX had the highest diagnostic sensitivity for recent concussions and highest specificity for older concussions among three eye-tracking devices, also noting its ease of use and lowest rate of poor-quality scans. Another study (May 2025) found EyeBOX useful in identifying concussion-related vision disorders in adolescents with persisting post-concussive symptoms.

Differential Diagnosis Support

EyeBOX aids in the diagnosis of concussion by measuring and analyzing subtle eye movements and cranial nerve function, generating a 'BOX score' (0-20). A score of 10 or more indicates a positive EyeBOX classification, consistent with the possible presence of concussion. The device produces a report including the BOX score, graphs, and other information for physician assessment. It is intended as an aid and should not be used as a standalone diagnostic device or a substitute for a CT scan. The expanded FDA label also supports assessing recovery against normative data.

Clinical Workflow Integration

The EyeBOX test is designed for quick integration into clinical workflows, with a patient video stimulus lasting 220 seconds (under 4 minutes) and immediate results (report available in 10 seconds). It is non-invasive, baseline-free, and portable. Oculogica provides training for healthcare technicians on device operation and for practitioners on report interpretation. The device has Wi-Fi and Ethernet capabilities for uploading scans and over-the-air software updates.

Decision Audit Trail

The provided information does not explicitly detail a 'decision audit trail' feature within the EyeBOX system. However, the device generates a report with a BOX score, graphs, and other data, which would typically be integrated into a patient's electronic health record, forming part of their clinical documentation.

Physician Tip

EyeBOX serves as an objective, baseline-free aid in concussion diagnosis for patients aged 5-67, particularly within one week of injury. Interpret the BOX score and eye-tracking metrics in conjunction with a comprehensive neurological assessment and other clinical findings. Remember that EyeBOX is not a standalone diagnostic and should not replace advanced imaging like CT scans for structural injuries. Utilize the expanded label to monitor patient recovery over time by comparing results to normative data, which can support return-to-activity decisions and therapy recommendations. Ensure proper training on device operation and report interpretation for accurate use.

EyeBOX offers Wi-Fi and Ethernet connectivity, facilitating the upload of scan data to remote servers and enabling over-the-air software updates. This suggests potential for integration with electronic health record (EHR) systems for streamlined data management and patient record keeping, though specific EHR integrations are not detailed. Partnerships, such as with XcelABLE, indicate its use in broader medical evaluations, suggesting adaptability for various clinical and medico-legal contexts.

At a glance

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Deployment Device Based With Cloud Connectivity

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Details

Category	Clinical Decision Support & Reference, Neurology AI
Pricing	Contact for pricing Contact Oculogica for device pricing; individual scans may be offered at a private pay rate (e.g., $100 per scan at some clinics)
Deployment	Device-based with cloud connectivity
Compliance
BAA Available	Unknown AI-estimated
HIPAA Compliant	Unknown AI-estimated
FDA Status	Yes AI-estimated EyeBOX received its initial FDA De Novo authorization in December 2018 as an aid in the diagnosis of concussion within one week of head injury in patients 5 through 67 years of age, in conjunction with a standard neurological assessment. Subsequent 510(k) clearances, including K201841 (dated 09/06/2020 as per user input, though other sources indicate a later submission date for K201841), have expanded its label to allow monitoring of recovery over time by comparing patient data to a normative population.
Integrations
EHR	Not specified
Specialties	Emergency Medicine, Neurology, Sports Medicine

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Press & Coverage

Concussion Alliance

EyeBOX is now cleared for acute concussion diagnosis and monitoring concussion recovery over time

Oculogica's EyeBOX, initially FDA-cleared in 2019, has received a new FDA label allowing it to monitor concussion recovery over time by comparing patient data to normative data. This new use aims to support clearer return-to-activity decisions and treatment recommendations.

2025-06

ProductDocket

FDA Clears Oculogica EyeBOX SNAP (K254086)

The FDA cleared Oculogica's EyeBOX SNAP on June 5, 2026, as a Class II neurology device. It functions as a brain-injury adjunctive interpretive oculomotor assessment aid, analyzing eye movements to assist clinicians in evaluating suspected concussions.

2026-06

Neurofounders

Oculogica Brings Eye-Tracking Concussion Assessment to the Sideline

Oculogica, founded in 2010, has developed objective concussion assessment tools, with its first product, EyeBOX, receiving FDA De Novo clearance in 2018. The company recently received 510(k) clearance for SNAP, a faster, 90-second assessment designed for sideline concussion testing.

2026-06

Healthy Blue Louisiana

MED.00137 Eye Movement Analysis Using Non-spatial Calibration for the Diagnosis of Concussion - Healthy Blue Louisiana

This document addresses the EyeBOX as the first baseline-free, eye movement analysis device to aid in concussion diagnosis. However, it states that eye movement analysis using non-spatial calibration is considered investigational and not medically necessary for concussion diagnosis.

2026-05

Military Medicine

Comparative Performance of Three Eye-Tracking Devices in Detection of Mild Traumatic Brain Injury in Acute Versus Chronic Subject Populations

This study compared the performance of three eye-tracking devices, including Oculogica's EyeBOX, in classifying mild traumatic brain injury (mTBI) subjects versus healthy controls. For the acute mTBI group, EyeBOX showed the highest Area Under the Curve (AUC) value of 0.950.

2024-08

Oculogica

New device can diagnose concussions using AI

Dr. Uzma Samadani, founder of Oculogica, was featured in an article discussing how the EyeBOX uses eye movements combined with AI to develop an unbiased objective diagnostic tool for concussions.

2023-04

PR Newswire

Oculogica Announces Launch of New EyeBOXu00ae Device

Oculogica announced the launch of its new EyeBOX device on March 1, 2022, following FDA clearance earlier that year. The updated device is lightweight, battery-operated, and portable, making it suitable for both clinical and sports settings.

2022-03

Minnetronix Medical

Oculogica Partners with St. Paul-based Minnetronix Medical

Oculogica and Minnetronix Medical announced a partnership on March 8, 2022, for the manufacturing of the EyeBOX. This collaboration combines Minnetronix's optical manufacturing expertise with Oculogica's diagnostic algorithms.

2022-03

Videos

Product demos, reviews, and walkthroughs for EyeBOX.

Oculogica EyeBOX

Oculogica

EyeBOX Demonstration

Bothwell Regional Health Center

Kevin Pearce Concussion Journey with HBOT and EyeBOX

Oculogica

Concussion: Physiology, Eye Tracking, and the EyeBOX

Athletic Therapy Ontario

Oculogica Eyebox

First Call Medical Center Gambrills

Oculogica EyeBOX

OCULOGICA

View all on YouTube

Frequently Asked Questions

How does EyeBOX integrate into our existing concussion assessment protocols and clinical workflow?

EyeBOX is a non-invasive, baseline-free eye-tracking device that takes approximately 4 minutes to complete, providing a BOX score within seconds. It is intended to be used as an aid in the diagnosis of concussion in conjunction with a standard neurological assessment, not as a standalone diagnostic tool.

What regulatory approvals does EyeBOX hold, and what are its specific indications for use?

EyeBOX received de novo FDA approval in 2018 as the first non-invasive, baseline-free aid for concussion diagnosis. It is cleared to measure and analyze eye movements to aid in diagnosing concussion within one week of head injury in patients aged 5 to 67, and its label has expanded to include monitoring recovery over time.

What are the known limitations or contraindications for using EyeBOX in clinical practice?

EyeBOX is not established for moderate or severe traumatic brain injury, patients with a Glasgow Coma Scale score less than 13, or those with structural brain injury. It also has limitations for patients with pre-existing eye movement disorders, visual acuity worse than 20/80, certain cranial nerve dysfunctions, or ADHD, and should not be used if the injury occurred more than one week prior.

How does EyeBOX compare to traditional concussion assessment methods or other emerging diagnostic technologies?

Unlike many traditional assessments and other eye-tracking technologies, EyeBOX does not require a pre-injury baseline test, making it valuable in acute injury settings where baseline data is often unavailable. While other tools like BrainScope One also aid in TBI assessment, EyeBOX specifically focuses on objective eye movement analysis to detect subtle neurological dysfunction.

How does EyeBOX ensure the privacy and security of patient health information, particularly regarding HIPAA compliance?

As a medical device used in healthcare, the manufacturer of EyeBOX, Oculogica, is expected to adhere to HIPAA regulations for the handling of Protected Health Information (PHI). This typically involves secure data collection, storage, and transmission, with measures in place to ensure confidentiality and integrity of patient data.

What clinical evidence supports the efficacy and accuracy of EyeBOX in diagnosing concussions?

EyeBOX has been reported on in 14 peer-reviewed studies. A pivotal clinical study showed a sensitivity of 80.4% and specificity of 66.1% in aiding concussion diagnosis, though some studies in specific populations have shown varying sensitivity. It provides objective data on eye movement abnormalities to augment clinical evaluation.

What is the typical cost associated with EyeBOX, and is it generally eligible for insurance reimbursement?

Specific pricing for the EyeBOX device is not publicly disclosed. However, it is a service that can be billed using applicable CPT/HCPCS codes, though reimbursement eligibility and rates will vary depending on individual insurance plans and payer policies. Physicians should consult with Oculogica for detailed pricing and explore local reimbursement guidelines.