The Food and Drug Administration approved the Argus II, the organization announced today, the first approved artificial retina to give limited vision to people who are blind. The device uses a small camera and transmitter mounted on a pair of eyeglasses, a video processing unit, and an implanted retina that can allow a patient to see limited movements and shapes.
“The device may help adults with RP who have lost the ability to perceive shapes and movement to be more mobile and to perform day-to-day activities,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health in an official statement.
The device is made for people with severe retinitis pigmentosa and was approved by the FDA for “limited humanitarian use,” which is a pathway to approval for those devices that treat or diagnose fewer than 4,000 people in the United States each year.
Earlier this year, the FDA approved new technology that fights blindness due to end-stage age-related macular degeneration.