Release date: 2015-06-25
The US Food and Drug Administration (FDA) recently approved a high-tech device that works with other ancillary equipment (such as a cane or guide dog) to help the blind to perceive the surrounding objects through the tongue and to "see" the world with the tongue. purpose.
The high-tech device, called the BrainPort V100, is battery-powered and looks like a pair of sunglasses. A miniature camera is mounted over the frame to capture the image. The software then converts the captured image information into electrical pulses that are transmitted through the wires. To a small, flat, conductive sheet with a series of electrodes. When the blind person wears the device and uses the tongue to contain the conductive sheet, a slight electrical pulse stimulus (vibration or tingling) can be felt on the tongue. After training and practice, the blind can learn to interpret the signal to determine the direction, position, size and shape of the object and determine whether the object is moving or still.
William Maisel, MD, deputy director and chief scientist of the FDA's Center for Equipment and Radiation Health, said innovations such as these medical devices are expected to help millions of blind people and help the blind to live a better and more independent life. According to the National Eye Institute (NEI), there were more than 1.2 million blind people in the United States in 2010. NEI expects that this number will reach 2.1 million by 2030 and reach 4.1 million by 2050.
The FDA conducted a comprehensive review of the BrainPort V100 through the de novo pre-marketing review channel, which is used to review some low-to-medium-risk related equipment that is completely different from legally marketed equipment.
Relevant clinical data supports the safety and effectiveness of the BrainPort V100, including several assessments (such as target recognition and text recognition) and oral health checks to determine the risks associated with the formation of conductive sheets in the oral cavity. The data showed that after 74 subjects completed one year of training, 69% of subjects were able to successfully identify objects during the recognition test. Some subjects reported burning, stinging or metallic taste associated with oral conductive sheets, and no serious adverse events associated with the device occurred.
The BrainPort V100, produced by Wisab, Wisconsin, USA, was approved for sale in the European Economic Area (EEA) in March 2013 and is currently available in Germany, Italy, Switzerland, and the United Kingdom for $10,000.
Source: Bio Valley
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