IRIS II Bionic Vision System developed by Pixium Vision, has finally got approval in France. It won the EU CE mark of approval to introduce their system to those with vision loss due to outer retinal degeneration.
Pixium Vision develops innovative bionic vision systems. Khalid Ishaque, CEO, Pixium Vision, stated in a press release,
The CE mark certification is a major step forward for Pixium Vision and for retinal dystrophy patients who have lost their sight. This recognition , by an independent expert body , validates the long – term multidisciplinary work that has result ed in market approval of th e IRIS ® II system. We will continue to develop our bionic vision system s with the aim to deliver improved visual perception and help retinal dystrophy patients lead more independent lives.
Image Source: IRIS II Bionic Vision System image from pixium-vision.com
What is CE Mark?
With CE marking companies are allowed to legally market and distribute products within the European market. The mark declares that the product complies with all applicable European Directives and Regulations.
Features of IRIS II
- A bio-inspired camera, that continuously captures changes in a visual scene with its time independent pixels.
The image from the camera is converted into electrical signals and transmitted to the implant. This implant stimulates the nerve cells of the inner retina.
- 150-electrode epi-retinal implant with
- Explantable and upgradeable design, this means the electrode array is secured on the retinal surface by a patented support system. This is meant to allow explantation/ future replacements/ upgrades.
- This will allow people with vision loss due to outer retinal degeneration lead more independent lives.
Pixium Vision is also developing a tiny, wireless, sub – retinal photovoltaic implant, named PRIMA. This innovative product is being developed for patients with age – related macular degeneration. As stated it is currently in preclinical studies and the company plans to begin clinical trials with this new product in Europe this year itself