Artificial Retina Developed with BMES Support Receives FDA Approval

Achievement date: 
2013
Outcome/accomplishment: 

The Argus® II retinal prosthesis became the first medical device to win U.S. Food and Drug Administration market approval as a bionic eye for patients in the United States.

Research that led to the device took place over two decades and derived major support from NSF’s Biomimetic MicroElectronic Systems Engineering Research Center (BMES ERC), which is headquartered at the University of Southern California. Center Director Dr. Mark Humayun (an M.D. and Ph.D.) led the research team responsible for this important medical breakthrough.

Impact/benefits: 

The FDA approval allows the prosthesis to be used by patients with retinitis pigmentosa, a sight-degrading condition that affects 1 out of every 4,000 U.S. citizens. At its current level of development, it allows blind patients to distinguish light and dark and see shapes, providing a functional level of sight.

The device showcases several technological breakthroughs that can be used to build future, more powerful integrated bionic devices for blindness and other debilitating conditions; it also demonstrates what can be accomplished through federal and private sector support of fundamental university research.

Explanation/Background: 

The Argus® II Retinal Prosthesis System transmits images wirelessly from a small, glasses-mounted camera to a 60-pixel microelectrode array implanted on a patient’s damaged retina. The array relays signals, via the optic nerve, that the brain interprets as images.

The implant allows some individuals with retinitis pigmentosa who are completely blind to locate objects, detect movement, improve orientation and mobility skills, and discern shapes such as large letters. 

The technology is manufactured by Second Sight Medical Products of Sylmar, Calif. Its commercial availability has come after nearly two decades of federal and private sector support for university and industry research and development, including substantial investment from NSF.

While under development for the marketplace, the Argus I and Argus II systems earned wide recognition, including a 2010 Popular Mechanics Breakthrough Award and a 2009 R&D 100 Award from R&D Magazine. After the FDA action, the technology and Dr. Humayun gained international attention as the story was picked up and distributed by Reuters, Yahoo!, NBC News, and many other popular media outlets.