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FDA Panel: Argus II Artificial Retina’s Benefits Outweigh Risks

Second Sight Medical Products gains FDA panel endorsement for humanitarian device exemption approval of Argus II, which would be the first artificial retina available to restore vision to the blind.

The benefits of Second Sight Medical Products Inc.’s Argus II implant outweigh the risks for restoring vision to the blind, FDA’s Ophthalmic Devices Panel concluded in a 19-0 vote Sept. 28.

The panel endorsement downplayed FDA concerns discussed at the meeting over numerous mid-course changes in the firm’s clinical trial as well as adverse events.

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