PARIS—Pixium Vision has been awarded a CE mark for its Iris II bionic vision system for people with vision loss from outer retinal degeneration. This 150-electrode epi-retinal implant features a design intended to be explantable and upgradeable.

“The CE mark certification is a major step forward for Pixium Vision and for retinal dystrophy patients who have lost their sight,” said Khalid Ishaque, CEO of Pixium Vision. “This recognition by an independent expert body, validates the long-term multidisciplinary work that has resulted in market approval of the Iris II system. We will continue to develop our bionic vision systems with the aim to deliver improved visual perception and help retinal dystrophy patients lead more independent lives.”

Iris II features a bio-inspired camera intended to mimic the functioning of the human eye by continuously capturing the changes in a visual scene with time independent pixels; an epi-retinal implant with 150 electrodes and an explantable design with the electrode array that is secured on the retinal surface by a patented support system that is intended to allow for explanation or future replacements or upgrades.