The EyeBox, recently cleared via FDA's de novo pathway, uses eye-tracking to provide objective information to aid in the assessment of patients with suspected concussion via a four-minute test.Oculogica
A hockey player goes to the emergency room with his coach to get checked out for a possible concussion. The clinicians can clearly see that the athlete has been badly hurt but there's another game coming up and all the player can think about is getting back out onto the ice so he tries to game the test.
This is a real example from a patient who was enrolled in a clinical trial evaluating a new concussion diagnosis device that uses an eye-tracking algorithm and does not rely on a baseline measurement for comparison. In this case, the athlete knew the answers he needed to give on the standard symptom checklist in order to avoid a concussion diagnosis, but the new device, dubbed the EyeBox, told a different story. The EyeBox was developed by New York-based Oculogica and just received marketing authorization from FDA via the de novo pathway.
"Our test showed he was really very concussed," Rosina Samadani, CEO of Oculogica, told MD+DI. "We learned that sometimes these sports players will do anything to make sure they can stay out there."
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. EyeBox uses eye-tracking to provide objective information to aid in the assessment of patients with suspected concussion via a four-minute test. Results of the pivotal DETECT clinical study of 282 patients at six independent sites who presented in the emergency room and concussion clinic with suspected traumatic brain injury (TBI) formed the basis of the Oculogica de novo application.
“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,” Samadani said. “We are thrilled to receive marketing authorization from FDA for the first non-invasive, baseline-free aid in the diagnosis of concussion. This field is a challenging one. Several key aspects of a diagnostic have thus far eluded researchers."
Most concussion assessment methods rely on subjective measures or baseline testing, Samadani said. The EyeBox could introduce a long-overdue way of objectively assessing a suspected concussion. The fact that this test does not require a prior baseline measurement is also considered a major advancement.
“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 field,” said Robert Spinner, MD, chair of the Department of Neurological surgery at Mayo Clinic.
The DETECT 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, thus providing objective data for healthcare providers to aid in the evaluation of patients with suspected TBI.
“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,” said John Leddy, MD, medical director of the University at Buffalo Concussion Management Clinic. “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.”
The company is already working on a portable version of the EyeBox and also pursuing future indications that may allow the device to aid in treatment decisions as well as diagnostic decisions.
Oculogica is engaged in additional studies to assess applications in specific, emerging, concussion therapies as well as in the diagnosis of other neurological conditions of the brain, such as elevated intracranial pressure. Eye tracking is an area of increasing recent interest in healthcare and consumer technologies. Google bought the eye tracking company Eyefluence in October 2016. Apple acquired Germany-based SensoMotoric Instruments in June 2017 and Facebook acquired Copenhagen-based eye-tracking startup The Eye Tribe in December 2017. Samsung has eye tracking capacity on its S4 device. All have expressed interest in the healthcare industry.