FDA approves 1st "bionic eye" for the blind

February 14, 2013 by MassDevice staff

U.S. health regulators showed some love to Second Sight Medical, granting FDA approval to the company's market-1st "bionic eye" system for patients with blindness due to a rare disease.

Second Sight retinal prosthesis

California medical technology maker Second Sight Medical is the 1st to bring a "bionic eye" to the U.S. market, landing FDA approval for the Argus II retinal prosthesis for treatment of blindness.

"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," Second Sight president & CEO Dr. Robert Greenberg said in prepared remarks. "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."

The device is comprised of 2 main components: an eyeglass-mounted camera and an electrical stimulator implanted in the eye.

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"The Argus II System works by converting video images captured by a miniature camera housed in the patient's glasses into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the surface of the retina," according to the company. "These pulses are intended to stimulate the retina's remaining cells resulting in the corresponding perception of patterns of light in the brain. The patient then learns to interpret these visual patterns thereby regaining some visual function."

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