Non-surgical Prescription Vision Aid Cleared by FDA for Use by People Who are Profoundly Blind

Industry News

FDA granted approval for marketing of a new device (BrainPort V100) that when used along with other assistive devices, like a cane or guide dog, can help orient people who are blind by helping them process visual images with their tongues.  BrainPort V100 is developed and marketed by Wicab, a Middleton, WI based-medical device company. It is a battery-powered device consisting of a video camera mounted on a pair of glasses and a small, flat intra-oral device containing a series of electrodes that the user holds against the tongue. Software translates digital information from the video camera into electrical signals that are then sent to the intra-oral device and perceived as vibrations or tingling on the user’s tongue. With training, the user learns to interpret the signals to determine the location, position, size, and shape of objects, and to determine if objects are moving or stationary.  The safety and effectiveness of the BrainPort V100 were supported by promising clinical data. According to the company’s press release, the potential advantages of the device are that it can be used regardless of the cause or duration of blindness, and does not require an intact optic nerve in order to function.

 

Original Article:

http://www.wicab.com/media/PL-000044%20A,%20Wicab%20Press%20Release%20US%20FDA%20Clearance%206-19-2015.pdf

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