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Artificial Eye Gets Expedited/Breakthrough Designation From US FDA

 
• By Elizabeth Orr

US FDA has admitted a Second Sight Medical device that the company says could help restore vision to many blind people to its Expedited Access Pathway for swifter review of groundbreaking products.

[Editors' note: Check out Medtech Insight's US Expedited Access Tracker for details on all products for which the sponsors have publicly disclosed acceptance into the EAP/Breakthrough program.]

Second Sight Medical Products Inc. announced Nov. 8 that US FDA has accepted its Orion Cortical Visual Prosthesis System to the Expedited Access Pathway (EAP), which allows products that...

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• By Shubham Singh

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