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New Concussion Device Gets FDA Approval

Andy Berg

A new tool for the diagnosing of concussions has received approval from the Food and Drug Administration.

New York-based startup Oculogica’s EyeBox is a non-invasive and baseline-free diagnostic tool that can detect concussions. The device can be used to detect concussions in children five and older and in adults up to 67 years of age. 

“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,” said Rosina Samadani, Ph.D., CEO of Oculogica in a press release. “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 healthcare 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 employs an eye-tracking algorithm enables it to be baseline-free, a major advancement for the field.

“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,” stated Dr. Robert Spinner, Chair of the Department of Neurological surgery at Mayo Clinic.

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