The FDA granted de novo approval Thursday to the BrainPort V100, a device that helps blind people process visual images with their tongues.
The battery-powered product — manufactured by Middleton, Wisc.-based Wicab — features a video camera mounted on glasses and a small, flat intra-oral component containing electrodes that users keep against their tongues. Images captured by the video camera are converted by software into electrical signals and are perceived as vibrations or tingling.
Once they learn to interpret the signals, users can figure out location, position, size and shape of objects and determine if the objects are moving or stationary.
This device has the potential to help millions of people, says Dr. William Maisel, chief scientist in the FDA’s Center for Devices and Radiological Health.
In the U.S., more than 1.2 million people are blind, according to National Institutes of Health estimates. — Jason Scott