FDA panel recommends approval for Second Sight's 'bionic eye'
And FDA advisory panel recommends that the federal watchdog agency approve a humanitarian device exemption for Second Sight's Argus II "bionic eye" 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.
The "bionic eye," which uses a head-worn camera to capture a scene and process it into electrical signals that are then sent to the cells in the eye, may pose long-term risks that increase over time , according to panel documents released ahead of the meeting. Nevertheless, the panel agreed that the federal watchdog agency ought to grant a humanitarian device exemption for the Argus II retinal prosthesis.