Ophthalmology devices maker Imagine Eyes’ imaging system receives CE Mark approval in European Union for clinical use.
Orsay, France-based Imagine Eyes landed CE Mark approval to market its rtx1 retinal camera, a device designed to image the retina at the cellular scale, which help clinicians observe the micro vascular structures that are frequently affected by vision-degrading diseases.
The newly approved rtx1 retinal camera, which is focused at the retina's cone photoreceptor layer to avoid image blurring, is the 1st adaptive optics platform system approved for clinical use, the company said.
"The technology is protected by 4 proprietary patents," director of global communications Mark Zacharria said in prepared remarks. "These cover different aspects of the device's optical architecture that enable its superior image quality."
The rtx1 retinal camera features flood illumination similar to a existing cameras, and can capture vascular patterns in the eye to generate images alongside other diagnostic techniques, such as fundus imaging or OCT, according to the press release.
Besides the regulatory win in the European Union, the rtx1 has received the Shonin mark in Japan. The device will land FDA clearance "hopefully by the end of Q2 2013," and receive other regulatory approvals in the emerging market, Zacharria noted.
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