FDA panel recommends approval for Second Sight's 'bionic eye'

September 28, 2012 by MassDevice staff

FDA advisory panel recommends that the federal watchdog agency approve a humanitarian device exemption for Second Sight's Argus II "bionic eye" retinal implant.

Second Sight's Argus II retinal implant

An FDA advisory panel recommended approval for a "bionic eye" designed to restore sight for the blind.

The FDA's Ophthalmic Devices Panel voted 17-2 that the Argus II device's benefits outweigh any potential risks; 18-1 that a clinical trial demonstrated "a reasonable assurance of safety;" and was unanimously agreed that the proposed minimum age requirement of 25 years is appropriate.

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