Oculogica’s New Small EyeBOX Gets FDA Clearance – Medical Alley Association

Oculogica’s New Small EyeBOX Gets FDA Clearance

At Oculogica it has been our mission to change the diagnosis of concussion for the better. In 2019 we brought you the first U.S. Food and Drug Administration (FDA)-cleared objective concussion diagnostic, the EyeBOX. I am excited to announce that the FDA has just cleared our next generation version of the EyeBOX.

The EyeBOX performs a test in under 4-minutes, utilizing a proprietary algorithm and machine learning to track patients’ eye movements in order to aid in diagnosing concussion. The test is non-invasive, and is not dependent on the patient’s literacy or fluency.  

The latest generation of our EyeBOX offers the same level of diagnostic power but is significantly more compact and weighs 11 lbs – making it small enough to fit in a backpack.

We are thrilled that we continue to have the broadest label of any concussion test in the industry in terms of age range and source of potential injury and are very proud of the work we are doing to raise the standard in the concussion diagnostic industry when it comes to clinical validation. We have now received 4 clearances from FDA since 2019, more than any other objective concussion assessment in the industry. 

We will be rolling out the new generation EyeBOX in the next few months.  

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