Saturday, February 09, 2013
A bionic eye system will soon be available in the United States, Discovery reports.
The market for retinal prostheses, once thought to be a far-off possibility, is now a reality. Industry pioneer Second Sight Medical Products, a spinoff from the Alfred Mann Foundation, has achieved its first $1 million in product revenue in Europe and may well be on the market in the U.S. in a matter of months if its HDE application is approved by the FDA. Though we’ve learned never to take FDA approval for granted, we’d be surprised to see the agency delay this application, given that blind people in Europe already have this device and given CDRH’s recent commitment to a more reasonable approval process.
The HDE route should work well for Second Sight, now that previous restrictions on profitability of HDE-approved devices have been removed. There’s still a 4,000 device limit in place but at $100,000 per unit, reaching that limit would be a good problem for Second Sight to have. In the meantime, the company can pursue a PMA for their device for the long term.
The Argus II Retinal Prosthesis System, developed by Second Sight Medical Products, aims to bring sight in varying forms to those who are visually impaired — most specifically, those suffering from a genetic disease called retinitis pigmentosa, which affects roughly 100,000 people in the U.S.
The Argus II system consists of 60 electrodes, implanted in a patient's retina, and a pair of glasses equipped with a mini-camera. Retinitis pigmentosa disrupts the eye's retinal photoreceptors, which help convert light into impulses that are decoded into images, resulting in various degrees of visual impairment. The Argus II, then, simply acts as a replacement photoreceptor.
The problem SecondSight.com is shielded under privacy, but most likely held by either the Florida guy with the Nazi dog that went under cover or the man who owns the Internet. With all the publicity they are probably killing it on parking because no one would ever know how to find them at their current address: http://2-sight.eu Come on you are selling a medical breakthrough with a $100K sku and named your firm without either securing the domain or changing the name to match an available one?
Check out the video demo- really cool stuff. The science fiction movies are no longer fiction. Those glasses look like the ones Tom Cruise wore in Minority Report.
Sources: SecondSight, Mashable and Neurotech Reports