Non-invasive test for concussion wins FDA nodMarch 5, 2019
Marketing permission has been granted by US FDA for EyeBOX, a non-invasive, baseline-free aid in diagnosis of concussion.
EyeBOX is easy to use test that collects and analyses over 100,000 data points to generate an objective assessment that is unique to each patient. It can be used as aids in the diagnosis of concussion in patients 5 to 67 years of age, Oculogica said.
EyeBOX uses eye-tracking to provide objective information to aid in the assessment of patients with suspected concussion via an easy to take, 4-minute test. A binocular camera then tracks each eye and gathers data that ultimately leads to a score that rates the severity of brain injury; a score =10 is Oculogica’s threshold for a concussion.
The FDA approval was supported by results from the DETECT clinical study which included 282 patients with suspected traumatic brain injury.
Results showed that compared with a clinical reference standard for a concussion, EyeBox had high sensitivity to the presence of concussion; a negative result was consistent with a lack of concussion.
The company plans to market the device for use in paediatrics ages 5 and older and adults up to 67 years of age, starting with a pilot launch for select, qualified sites.