From: Sheila via fcb-l [mailto:fcb-l@xxxxxxxxxxxx]
Sent: Saturday, June 20, 2015 2:44 PM
Subject: [fcb-l] new FDA release
FDA allows marketing of new device to help the blind process visual signals
via their tongues
For Immediate Release
June 18, 2015
The Food and Drug Administration today allowed marketing of a new device
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.
The BrainPort V100 is a battery-powered device that includes 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 their tongue. Software
converts the image captured by the video camera in to electrical signals
that are then sent to the intra-oral device and perceived as vibrations or
tingling on the user’s tongue. With training and experience, 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.
“Medical device innovations like this have the potential to help millions of
people,” said William Maisel, M.D., M.P.H., deputy director for science and
chief scientist in the FDA’s Center for Devices and Radiological Health. “It
is important we continue advancing device technology to help blind Americans
live better, more independent lives.”
According to the National Institutes of Health’s National Eye Institute
(NEI), in 2010 more than 1.2 million people in the United States were blind.
NEI projects that number of Americans who are blind will rise to 2.1 million
by 2030 and 4.1 million by 2050.
The FDA reviewed the data for the BrainPortV100 through the de novo
premarket review pathway, a regulatory pathway for some low- to
moderate-risk medical devices that are not substantially equivalent to an
already legally-marketed device.
Clinical data supporting the safety and effectiveness of the BrainPort V100
included several assessments, such as object recognition and word
identification, as well as oral health exams to determine risks associated
with holding the intra-oral device in the mouth. Studies showed that 69
percent of the 74 subjects who completed one year of training with the
device were successful at the object recognition test. Some patients
reported burning, stinging or metallic taste associated with the intra-oral
device. There were no serious device-related adverse events.
BrainPort is manufactured by Wicab, Inc., in Middleton, Wisc.
The FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is responsible
for the safety and security of our nation’s food supply, cosmetics, dietary
supplements, products that give off electronic radiation, and for regulating