FDA OKs Device to Monitor Blink Reflex, Potential Way of Detecting MS Early

EyeStat, a portable device to measure blink reflex, has been cleared for use by the U.S. Food and Drug Administration (FDA).

On the heels of promising results for assessing brain injury, the manufacturer, Blinktbi, plans to test if the device can be used for the early detection of the onset of neurological disorders, including multiple sclerosis (MS).

When a sensory stimulus makes contact with the eye, the blink reflex is triggered. The stimulus prompts nerve cells to send a signal that travels through a nerve into the brain; in turn, the brain responds sending a signal back to the eye, telling it to blink. Ophthalmologists use this reflex to test for nerve damage, and neurologists can use it to evaluate brain function.

EyeStat is a a portable, lightweight device that stimulates a blink reflex by delivering five light puffs of air to the corner of the eye, to trigger the blink reflex in a 20-second test. The blink reflex is measured by high-speed cameras that record the eye. The test is non-invasive and allows the measurement of reflex time, duration, and other variables. Results come out in less than a minute.

The FDA’s approval is the milestone of a collaborative effort betweren scientists and entrepreneurs; the original idea came from Nancey Tsai, MD, a professor at the Medical University of South Carolina who wanted to create a portable blink “reflexometer” to monitor traumatic brain injuries in athletes during games.

Working with tech incubator Zucker Institute for Applied Neurosciences (ZIAN), Tsai took the first steps toward the commercialization of the device. ZIAN filed a patent to protect the idea in 2013, and produced the first prototype in collaboration with Lt. Col. Dena Garner, PhD, professor and director at The Citadel.

“Blinktbi was able to shrink the device down to a small portable device designed for sideline or clinic use. They also significantly expanded the research and testing, and obtained FDA clearance for the EyeStat device,” Mark Semler, EyeStat’s co-inventor and CEO of ZIAN, said in a news story.

For now, the FDA’s clearance only supports EyeStat use as a measurement device, and not yet as a diagnostic tool to detect particular conditions.

Nonetheless, Blinktbi is investigating its use to identify clinically relevant changes in the blinking of people suspected to have a traumatic brain injury.

“Our clinical trials show our blink reflex changes with any trauma to the brain,” said Ryan Fiorini, PhD, Blinktbi’s co-founder and chief operations officer.

“We are also excited to say that now that we have FDA clearance for the blink reflex, we are beginning multiple studies looking at indications in a number of different fields,” Fiorini added. “These include testing for sobriety and early onset of neurological diseases, such as multiple sclerosis and Alzheimer’s disease.”

More studies, though, will be needed before such applications can be confirmed, and each would require a separate FDA approval.

EyeStat is currently being sold to high school, collegiate, and professional sports teams across the U.S. Data collected in the field at these places will help Blinktbi assess if the device is able to effectively diagnose traumatic brain injury, or concussions.