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'Bionic Eye' Approved by US Regulators

A California-based medical company has developed a product that will help victims of blindness and poor eyesight all over the country.

On Friday, U.S. regulators approved a ‘bionic eye’ created by Second Sight Medical Products, Inc., which will serve as the first ever retinal implant for grown-ups who suffer from advanced retinitis pigmentosa. The condition results in slow but steady loss of overall vision and (possibly) eventual blindness.

The Argus II Retinal Prosthesis System is viewed as a game-changer by medical industry experts.

"While the Argus II Retinal Prosthesis System will not restore vision to patients, it may allow them to detect light and dark in the environment, aiding them in identifying the location or movement of objects or people," the US Food and Drug Administration said in a statement announcing its decision.

A relatively small camera, transmitter and video processing unit are key components of the new device. That and an implanted retinal prosthesis which 'replaces the function of degenerated cells in the retina.'

"This new surgically implanted assistive device provides an option for patients who have lost their sight to RP (retinitis pigmentosa), for whom there have been no FDA-approved treatments," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.

"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 FDA approved Argus II as a humanitarian use device – a distinction only used for things that treat 4,000 or fewer people on an annual basis.

"With this approval, we look forward to building a strong surgical network in the United States and recruiting new hospitals that will offer the Argus II retinal implant," said president and CEO Robert Greenberg.

"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."



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