Oculogica Inc., a pioneer in the development of non-invasive, objective diagnostic tools for brain injuries, is proud to announce that the U.S. Food and Drug Administration (FDA) has granted an expanded label for its groundbreaking EyeBOX® technology. The updated label permits clinicians to compare a patient with an injury against a normative population, allowing physicians to assess recovery, therapy and return to activity after a concussion.
EyeBOX was the first, and still only, FDA-cleared aid in concussion diagnosis that uses eye-tracking technology to provide objective data, without requiring a pre-injury baseline test. EyeBOX’s first clearance was in 2018, and led the way for the industry with a de novo authorization.
The latest FDA clearance, received by the company on April 6, 2025, enhances its utility in clinical settings by giving healthcare providers broader and more comprehensive context for interpreting individual test results, using the comparisons of multiple eye-tracking metrics against a normative population to track patient recovery and provide support for therapeutic interventions. This is the broadest label in the industry with respect to age range, time since injury, and type of injury.
“We are thrilled to receive FDA clearance for this expanded label,” said CEO, Dr. Rosina Samadani. “This clearance is the result of several years of work and is a critical advance for the industry, and patients. It is also another first by the company for the industry. We are proud to lead the way, yet again, and we will continue to do so. This innovation – being first – is part of our company DNA.”
Oculogica received its first FDA clearance for EyeBOX in December 2018. That clearance was a de novo authorization, as there was no other concussion diagnostic of its kind cleared by FDA. Since then, the company has received four additional 510(k) clearances. This most recent clearance is the largest FDA label expansion in the industry since the first EyeBOX clearance in 2018.
For more information about EyeBOX and Oculogica’s technology, visit www.oculogica.com.