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Pixium receives approval to initiate clinical trial of bionic vision system
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The Medicines and Healthcare Products Regulatory Agency in the United Kingdom has granted approval for Pixium Vision to initiate a clinical trial of the Iris II bionic vision system in patients who have lost sight due to retinitis pigmentosa, according to a press release.
The system consists of a mini bio-inspired camera, an epiretinal implant with 150 electrodes and an explantable design, the release said.
In addition, the Moorfields Eye Hospital NHS Foundation Trust will participate in the trial, which will broaden the trial centers of excellence to sites in France, Germany and Austria.
The CE mark approval process for the device was initiated in December, and depending on the timing of the approval, commercialization of the system may begin later this year.