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The device, called the Argus II Retinal Prosthesis System and made by Second Sight Medical Products of Sylmar, Calif.
FORBES: FDA Approves First Bionic Eye
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The FDA reviewed data that included a clinical study of 30 study participants with RP who received the Argus II Retinal Prosthesis System.
FORBES: FDA Approves First Bionic Eye
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Results from the clinical study show that most participants were able to perform basic activities better with the Argus II Retinal Prosthesis System than without it.
FORBES: FDA Approves First Bionic Eye
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Second Sight's Argus II contains 60 electrodes, but some other scientists say that for a retinal prosthesis to be truly useful to patients, hundreds are needed.
WSJ: The Quest to Create A Bionic Eye Gets Clearer
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The Argus II was approved with the CE mark for use in Europe in 2011 and the Retinal Prosthesis system is the first prosthesis of its kind in the world.
FORBES: First Bionic Eye For US Market Awaits Approval From FDA
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Those in the US suffering from blindness due to retinis pigmentosa (RP) will now be able to regain some vision bionically for the first time ever, thanks to Second Sight's Argus II retinal prosthesis.
ENGADGET
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The FDA approved the Argus II Retinal Prosthesis System as a humanitarian use device, an approval pathway limited to those devices that treat or diagnose fewer than 4, 000 people in the United States each year.
FORBES: FDA Approves First Bionic Eye
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The artificial retina, called the Argus II Retinal Prosthesis System, is the first implantable device to treat the condition and is approved for people over age 25 with advanced RP who can see some light.
CNN: FDA approves first bionic eye
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Normal vision is based on more than one hundred million receptors in each eye, but it is impossible to squeeze that many electrodes into a tiny device that has to lay on the retina, said John Wyatt, a professor in the department of electrical engineering at MIT who has been working on a retinal prosthesis since 1988.
WSJ: The Quest to Create A Bionic Eye Gets Clearer