Oculogica, a leader in concussion diagnostics, announced that the U.S. Food and Drug Administration (FDA) granted clearance for the Company’s next generation EyeBOX.
The EyeBOX is the first objective testing device authorized by the FDA as an aid in the diagnosis of concussion. 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 the EyeBOX offers the same level of diagnostic power but is significantly more compact and weighs 11 lbs, making it light enough to carry in a backpack. The FDA label includes both pediatric and adult populations and concussions from any type of activity.
“Our EyeBOX device offers a leap forward in concussion diagnosis,” said Rosina Samadani, PhD, CEO of Oculogica. “Our latest generation device has the same diagnostic power as the previous generation. The new lightweight form factor allows it to be easily transported. Concussions happen everywhere and our latest device was designed with that in mind.”
“We are also 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, which is more than any other baseline-free concussion assessment in the industry,” noted Dr. Samadani.
Oculogica expects to roll-out the next generation EyeBOX in early Spring of 2022.