Pixium Vision wins CE Mark for Iris II retinal prosthesis

French retinal implant maker Pixium Vision said Monday it won CE Mark approval in the European Union for its Iris II bionic vision system designed for individuals with vision loss from outer retinal degeneration. The Iris system is comprised of a retinal implant and a pair of camera-mounted glasses connected to a “pocket computer.” The computer processes images captured by the glasses and transmits the data into a signal that’s transferred back and projected onto the intraocular implant, where it stimulates the optic nerve and generates images that the brain learns to interpret as visual signals. “The progress in research with vision restoration of some visual perception is a reality, particularly with retinal prostheses. This research is addressing the growing patients’ expectations and their hope to regain some sight. On behalf of our member organisations, we are delighted to welcome the new bionic vision system IRIS II that may offer people suffering from retinitis pigmentosa a new treatment option with a design that is intended to be explantable and upgradeable,” Retina International prez Christina Fasser said in a press release. The Iris II system is a 150-electrode epi-retinal implant designed to be upgradeable and explantable, and integrates continuous image capture with “time independent pixels” and 3 times the number of electrodes than its previous version, Pixium said. “The CE mark certification is a major step forward...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Optical/Ophthalmic Regulatory/Compliance Pixium Vision Source Type: news