FDA gives nod to Beaver Dam native’s concussion detection device

January 11, 2019

A first-of-its-kind concussion detection device has a Beaver Dam connection.

The federal Food and Drug Administration has granted marketing authorization of the EyeBOX, a device from the company Oculogica that helps diagnose concussions. Beaver Dam Community Hospitals participated in clinical trials involving athletes at Beaver Dam High School and Wayland Academy to help understand how the device could be used.

Rosina Samadani, a biomedical engineer who grew up in Beaver Dam and attended Wayland, is the CEO of Oculogica. She said the device is the first of its kind. Her sister, Dr. Uzma Samadani, invented the device and founded Oculogica, which Rosina now directs.

“Everybody has their own exam for a concussion. It might be a symptom checklist,” Rosina Samadani said. “A lot of those symptoms are pretty subjective. You could feel that way even if you didn’t have a concussion.”

The EyeBOX is a 4-minute test. Patients put their chins and foreheads on a rest and watch a slow-moving, high-fidelity video as the device tracks their eye movement.

After the test is over, patients receive a score that helps to determine whether the patient might have a concussion. The EyeBOX does not require a baseline test that athletes will take at the beginning of a season to compare to results from a later, traditional test if they are suspected of having a concussion.

Samadani said the device makes everything more objective and consistent, less likely to be “gamed” or misdiagnosed with symptoms that may not actually be from a concussion, like the stress of being in the emergency room.

“It’s actually a measure of your physical eye movement and that’s not something that you can control with respect to each other,” she said. “Each eye has to move in the same direction as the other eye. It’s a very difficult thing to control, especially over 4 minutes. We removed that subjectivity, which is what makes this test very, very different.”

Samadani said that Beaver Dam was an integral part in developing the device. Athletes at Wayland used it in a previous season.

“It was a lot more reliable in that there were no glitches from a technological perspective,” said Wayland athletic director Phil Tallman. “The kids went into the sit-down and would be done in 5 minutes. The readings were there to let them know whether they were in good health.”

He said the device takes out a lot of the guesswork and he would be interested in looking into it in the future.

Oculogica is going to start with a pilot launch at a number of select sites. The company is first looking at the medical side of the market, trying to change the way brain injuries are addressed and working on creating a unique medical code for hospital billing, before moving more into the consumer side.

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