FDA panel: Approve the 'bionic eye', with conditions

October 1, 2012 by Ingrid Mezo

An FDA advisory panel recommends a humanitarian device exemption for Second Sight's Argus II "bionic eye," provided the company conducts a rigorous post-approval study.

Second Sight's Argus II bionic eye

An FDA advisory panel recommended that the federal watchdog agency grant a humanitarian device exemption to Second Sight Medical Products' Argus II retinal prosthesis system, designed for patients who are profoundly blind due to a rare condition called retinitis pigmentosa.

Patients with retinitis pigmentosa have either bare light perception or none at all. There is currently no cure and no available treatment for the rare condition that's diagnosed about 250 times each year.

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