FDA Approves Oculogica's EyeBox Eye-Tracking Concussion Test

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NEW YORK—Oculogica Inc., which develops algorithm-based neuro-diagnostic tools, said last week the FDA granted its De Novo request for the commercialization of EyeBox, the first non-invasive, baseline-free tool to aid in the diagnosis of concussion, according to the company’s announcement. FDA issued the approval Dec. 28, the announcement stated. Oculogica plans to market the device for use in pediatrics ages 5 and older, and adults up to 67 years of age, starting with a pilot launch for select, qualified sites, the announcement stated.

EyeBox uses eye-tracking to provide objective information to aid in assessment of patients with suspected concussion via an easy to take, four-minute test. Results of the pivotal “DETECT” clinical study of 282 patients who presented in the emergency room and concussion clinic with suspected traumatic brain injury (TBI) formed the basis of the Oculogica De Novo application, the announcement stated.



“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,” Rosina Samadani, chief executive of Oculogica, said in the announcement. “We are thrilled to receive marketing authorization from FDA for the first non-invasive, baseline-free aid in diagnosis of concussion. This field is a challenging one. Several key aspects of a diagnostic have thus far eluded researchers.

Before now, concussion assessments have relied on subjective measures or baseline testing. This authorization by FDA is a significant milestone for the company and, more importantly, heralds a new era for concussion diagnosis and management for patients and health care practitioners.”

Other diagnostics require a baseline test, typically generated at the beginning of a sport season, pre-injury, and is compared to subsequent test results at the time of a suspected concussion. In many situations, a baseline concussion assessment is not feasible, especially when evaluating trauma patients in the emergency room. 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, a major advancement for the field, the company noted in its announcement.

“Eye-tracking will change the practice of emergency care for concussion and will greatly assist a large number of patients,” Dr. Robert Spinner, chair of the Department of Neurological surgery at Mayo Clinic, said in the announcement.

The company also noted in its announcement that eye tracking is an area drawing increasing interest. Google purchased the eye tracking company Eyefluence in October 2016, Apple acquired Germany-based SensoMotoric Instruments GmbH in June 2017 and Facebook acquired Copenhagen-based eye-tracking startup The Eye Tribe ApS in December 2017. Samsung has eye-tracking capacity on its S4 device, also.