A new medical device that tracks eye movements can help medical professionals diagnose concussions, and is the first noninvasive, baseline-free test of its kind to be approved by the Food and Drug Administration (FDA).
The EyeBOX, made by Oculogica, uses proprietary technology to collect and analyze more than 100,000 data points relating to cranial nerve function and eye movements to generate an objective assessment of concussion in less than four minutes. Oculogica plans to market the device for use in children and adults ages 5 to 67 years, starting in select, qualified sites.
What is unique about the EyeBOX is that it does not require a baseline test to determine the severity of a traumatic brain injury. Baseline concussion assessments are not always possible, especially in emergency situations. These tests can also be “gamed,” or memorized, by athletes and military personnel, which can throw off evaluations.
“Eye-tracking will change the practice of emergency care for concussion and will greatly assist a large number of patients,” said Robert Spinner, MD, chair of the department of neurological surgery at Mayo Clinic in Rochester, Minnesota. “The result will be more consistent and objective diagnoses of concussion in the emergency room and clinic, and eventually on the (playing) field.”
Clinical trials on the device showed that the EyeBOX had a high sensitivity to the presence of concussion. Negative EyeBOX results also were consistent with a lack of concussion.
“Before now, concussion assessments have relied on subjective measurers or baseline testing,” said Rosina Samadani, PhD, founder and CEO of Oculogica. “This authorization by FDA … heralds a new era for concussion and diagnosis and management for patients and health care practitioners.”