The US Food and Drug Administration (FDA) will allow marketing of EyeBOX (Oculogica), the first noninvasive, baseline-free test to help diagnose concussion.
The company plans to market the device for use in children ages 5 and older and adults up to 67 years of age, starting with a pilot launch for select, qualified sites.
EyeBOX uses eye-tracking to provide objective information that helps clinicians assess patients who have a suspected concussion with a simple, 4-minute test that does not require a baseline test.
In many situations, a baseline concussion assessment is not feasible, particularly when evaluating trauma patients in the emergency department. Baseline tests can also be "gamed" or memorized so that athletes and military personnel can pass a subsequent test. EyeBOX’s unique eye-tracking algorithm enables it to be baseline-free, the company announced.
"Eye-tracking will change the practice of emergency care for concussion and will greatly assist a large number of patients. The result will be more consistent and objective diagnoses of concussion in the emergency room and clinic, and eventually on the [playing] field," Robert Spinner, MD, chair of the department of neurological surgery at Mayo Clinic in Rochester, Minnesota, said in a statement.
EyeBOX was evaluated in a clinical trial known as DETECT, which enrolled 282 patients at six clinical sites in the US and compared the EyeBOX results to a clinical reference standard for concussion in patients presenting to emergency departments and sports medicine clinics with suspected head injury.
The study showed that the EyeBOX had high sensitivity to the presence of concussion and that a negative EyeBOX result is consistent with a lack of concussion, the company said.
"Oculogica’s extensive clinical research and validation have shown we can provide an objective assessment to healthcare providers when evaluating patients with suspected mild traumatic brain injury," Rosina Samadani, PhD, founder and CEO of Oculogica, said in the statement.
"Before now, concussion assessments have relied on subjective measures or baseline testing. This authorization by FDA...heralds a new era for concussion diagnosis and management for patients and healthcare practitioners," said Samadani.
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Cite this: FDA Clears Novel Eye Tracking Test to Detect Concussion - Medscape - Jan 08, 2019.