Dr. Samadani Receives FDA Approval for Concussion-Detection Device

After years of clinical testing, Oculogica has launched their newest medical device created by the Department of Neurosurgery’s Uzma Samadani, MD, PhD.

The group has gone to launch after receiving approval from the U.S. Food and Drug Administration on their new product called the EyeBox. The EyeBox detects signs of concussions by tracking a patient’s eye movements as they watch a 4-minute video.

This exam differs from “baseline” concussion tests because they are quantifiable and cannot be manipulated by a patient looking to avoid brain injury diagnosis. With objective measurement, the EyeBox will be able to identify many different types of brain injuries.

The use of the EyeBox will transform how concussions and mild traumatic brain injuries are diagnosed because of the elimination of the baseline tests.

The FDA has approved this device for physician use only. "Certainly a consumer device that could help people make decisions at home would be great. But that is not where we are yet," Dr. Samadani said in an interview with the Star Tribune.

Dr. Samadani is a founder and board member of Oculogica, but has not worked with the company since 2015. Her sister, Rosina Samadani is the CEO, starting as a biomedical engineer with a business background. Rosina Samdani noted to the Star Tribune that a few of these devices are already in the field at various clinical trial sites.

"I think we want to first establish ourselves as the medical standard that can then be translated into a consumer device," Dr. Samadani told the Star Tribune. "Really what we are talking about is changing the way brain injury is diagnosed and defined."