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article imageU.S. FDA approves first bionic eye

By Leigh Goessl     Feb 15, 2013 in Technology
The U.S. Food and Drug Administration has approved the first bionic eye. The implantable device was developed to help adults with limited vision from a rare genetic disorder to be able to see.
The U.S. Food and Drug Administration (FDA) has approved what is being referred to as the first bionic eye. The implantable device, developed by California-based Second Sight Medical Products, Inc., is called the Argus II Retinal Prosthesis System.
The Argus II Retinal Prosthesis System is approved to treat patients with advanced retinitis pigmentosa (RP).
“This new surgically implanted assistive device provides an option for patients who have lost their sight to RP – for whom there have been no FDA-approved treatments,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, in a press release. “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.”
The bionic eye's makeup includes an implanted artificial retina, a small video camera, video processing unit and a transmitter mounted on a set of eyeglasses. Combined, this is designed to replace the damaged cells and "may improve a patient’s ability to perceive images and movement," said the FDA's press release.
Designed for adults over 25 with severe RP, the clinical study of 30 participants showed that patients were able to "perform basic activities better" with the implant than without it. Nineteen of the 30 study patients experienced no adverse effects, the other 11 patients did suffer from "serious" adverse effects.
"This is a game changer in sight-affecting diseases, that represents a huge step forward for the field and for these patients who were without any available treatment options until now," said Second Sight Chief Executive Robert Greenberg.
According to USA Today, this device had already received approval by European authorities.
More about Bionic eye, Fda, US Food and Drug Administration, food and drug administration, Blindness
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