Retinal Implant AG wins its 1st CE Mark for a wireless sub-retinal implant that reverses blindness caused by retinitis pigmentosa.
European healthcare regulators this month granted CE Mark approval to Retina Implant AG's Alpha IMS, a tiny eye implant that restores "useful" vision in patients blinded by retinitis pigmentosa.
Reutlingen, Germany-based Retina Implant AG, founded in 2003 from a German research institute spinout, touts the technology as "artificial sight." The Alpha IMS chip is implanted beneath the retina, where it sends electrical impulses to the brain to help restore visual capacity.
This is company's 1st stamp of approval in Europe, and the Alpha IMS device has already been implanted in 36 patients, according to a company statement. Retina Implant AG claims its microchip implant's 1,500 electrodes are more than any other device device used in humans.
"We are delighted that our subretinal implant has received CE marking, validating the safety and potential benefits of our revolutionary product to patients and physicians," CEO Walter-G Wrobel said in prepared remarks. "We also want to thank all of the patients who participated in our clinical trials, as without their contributions, this day would not be possible."
A different kind of retinal implant called Argus II, made by Second Sight, hit the shelves in the States following FDA approval earlier this year. The company is slated to set up shop at 12 medical centers across the U.S. to begin consultations for the device.
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