Healthcare Technology Featured Article

January 30, 2013

Eyes on FDA: Will it Approve 'Bionic Eye' System for Visually Impaired?



U.S. regulators may soon approve technology that promises to restore vision to a few categories of patients struggling with blindness.

It is part retinal implant and part glasses/video-camera. It ends up offering what the news media is calling a “bionic eye.”

“It uses a video camera embedded in a pair of eyeglasses to collect visual input in the form of light and transmit it to the implant as an electrical signal,” Fox News explained in a report.

Formally it is called “Argus II” and is manufactured by Second Sight Medical Products Inc. of Sylmar, Calif. It uses a retinal prosthesis and targets those who lost their sight from Retinitis Pigmentosa, which impacts some 100,000 Americans. Another group it may help is those with severe macular degeneration.

If it gets Food & Drug Administration (FDA) approval, it will provide the first bionic eye offered in the U.S. market. The FDA has given the product a preliminary stamp of approval. On Sept. 28, an FDA Ophthalmic Devices Advisory Panel unanimously voted “the probable benefit of the Argus II Retinal Prosthesis System outweighs the risks to health,” according to a company statement.

The Argus II was approved for use in Europe in 2011.

Researchers have spent many years developing the technology. There were many challenges along the way.

“No one really thought it would be possible because the tissue around the eye is so soft and delicate,” Mark Humayun, an eye specialist at the University of Southern California, was quoted by Forbes. “If we continue to develop this type of technology and begin to understand the new electrical language of pulses to the brain, to the eye, we can apply it to other parts of the body and we can change our world and how we relate to it.”

“Software upgrades will allow us to do more for people – because the implants don’t need to change, the glasses can be enhanced with software upgrades,” Humayun added. ”Software upgrades that allow you have a digital zoom, think of your iPhone with the zoom feature – now it would be possible to do that with your eye.”

Humayun was the co-inventor of the Argus II.

After it gets final FDA approval, it will be available in U.S. clinics.

Meanwhile, Second Sight Medical recently submitted documents to the Securities and Exchange Commission for a $25 million funding round involving investors, according to MassDevice.com.

In addition, Massachusetts Institute of Technology (MIT) and Stanford University are trying to develop stronger versions of the Argus II. 




Edited by Brooke Neuman




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