US regulators approved a so-called bionic eye, giving hope to people with a rare genetic disease.
Developed by California-based Second Sight Medical Products, Inc., the Argus II Retinal Prosthesis System is the first retinal implant for adults with advanced retinitis pigmentosa that results in the gradual loss of vision and can lead to blindness.
The device includes a small video camera and a transmitter mounted on a pair of glasses, as well as a video processing unit and an implanted retinal prosthesis that replaces the function of degenerated cells in the retina.
Already greenlighted by European regulators, the FDA approved the Argus II as a humanitarian use device, which is limited to instruments that treat or diagnose fewer than 4,000 people in the United States annually.
Second Sight welcomed the news, calling it a game changer.
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