EyeStat Device for Measuring the Blink Reflex Gets Clearance By U.S FDA

EyeStat device by blinktbi can facilitate in measuring or monitoring a person’s natural blink reflex. Blinktbi got successful in receiving FDA clearance for this lightweight and portable device.

The presence of mechanical or sensory stimuli in the eye’s vicinity activates natural blink reflex. These stimuli act on specific optic nerves. These nerves carry the message to the brain, that in return will send a signal to the eye, causing it to blink.

Measuring the blink reflex also have some clinical significance. Ophthalmologists can use it to look for any disease that affects these optic nerves or their communication with the brain. Whereas, monitoring blink reflex can also facilitate neurologists in assessing the function of the brain.

Using the EyeStat device, the eye corners are provided with five light gusts of carbon dioxide for triggering optic nerves and initiating blink response in the eye. These food-grade gusts are delivered at random intervals over a time period of 20 seconds.

To monitor and record the blink reflex, more than 12,000 pictures are taken by the device during this time. EyeStat can mainly provide information regarding five things. It tells how much time the optic nerves take in carrying the signal to the brain and then causing the stimulated eye to blink in response to the air stimulus.

Moreover, the device also provides information about the lag time between the blinking of stimulated eye to the blinking of non-stimulated one, the frequency of blinks soon after receiving a mechanical stimulus, the time for which eye remains closed during a blink reflex, and the position of a person’s eyelid when it is closed or when a person is merely looking forward.

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The FDA clearance of EyeStat has allowed blinktbi to advertise this device as a way to measure and demonstrate the blink reflex in response to mechanical stimuli. But up till now, it hasn’t received any approval for marketing as a device to diagnose some specific clinical conditions.

The blinktbi is carrying out research to check that if this portable and lightweight device can be used to detect any variations in the blink reflex in individuals who are subjectively diagnosed with TBI.

A few of the findings of these clinical trials indicate that traumatic brain injury (TBI) can lead to variations in the natural blink reflex. The idea to invent such a device came from Nancey Tsai, an assistant professor at MUSC. She wanted to invent a portable Reflexometer that would allow monitoring the blink reflex of athletes during games and diagnose TBI.

Tsai joined hands with the Zucker Institute for Applied Neurosciences (ZIAN) to create such a portable device. After creating a prototype, the right to test, develop, and eventually advertise this technology was given to blinktbi by ZIAN.

The initially tested devices were large and required to be carried out on wheels, thus providing a limitation. Later, blinktbi efforts made it possible to shrink the size of the device allowing its use in the clinics.

Blinktbi has also obtained FDA clearance for EyeStat. Currently, many high schools, college and professional sports teams are using this device to measure the blink reflex initiated by mechanical stimuli.

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