• FDA OKs New Eye-tracking Concussion Diagnosis Tool

    January 17, 2019, 12:17 pm News Staff – The FDA recently granted Oculogica Inc. authorization to market its EyeBox product, which the company said is the first noninvasive, baseline-free tool to aid in the diagnosis of concussion.

    The EyeBox uses a four-minute eye-tracking test intended to help physicians objectively evaluate patients ages 5-67 with suspected concussions.

    Oculogica, which was founded by Uzma Samadani, M.D., Ph.D., associate professor of neurosurgery at the University of Minnesota Medical School, plans to start marketing the device with a pilot launch for select sites.

    "Oculogica's extensive clinical research and validation have shown we can provide an objective assessment to health care providers when evaluating patients with suspected mild traumatic brain injury (TBI)," said Rosina Samadani, Ph.D., CEO of Oculogica, (and Uzma's sister) in a news release.

    injured cyclist clutching his head

    EyeBox does not require preinjury baseline tests, such as those given at the start of a sport season to be compared to test results later, after a suspected injury.

    Baseline assessment are not always available, such as during evaluation of trauma patients in the ER, and they can be "gamed" by those who want to pass a subsequent test without being diagnosed with concussion.

    "Looking beyond this milestone, EyeBox has the potential to aid in the diagnosis of other neurological conditions and may benefit researchers developing therapies for TBI and concussion," John Leddy, M.D., medical director of the University at Buffalo Concussion Management Clinic said in the release. "Development of treatments for concussion is challenging because there are few reliable outcome measures. EyeBox may offer one solution to this challenge, providing researchers with an objective oculomotor assessment tool."

    Oculogica said it's involved in additional studies to assess applications in specific, emerging concussion therapies, as well as in diagnosis of other neurological conditions of the brain, such as elevated intracranial pressure.

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