EU Grants CE Mark Approval for Imagine Eyes Retinal Camera

Posted in Ophthalmology by Bob Michaels on November 20, 2012

Imagine Eyes, a medical device manufacturer based in Orsay, France, received CE Mark approval in the European Union for its new retinal imaging system. According to information released by the company, the product is the first clinically-approved adaptive optics platform system.

The rtx1 retinal camera system is used to take images of the retina in the eye. Unlike other products on the market, the rtx1 can take images at the cellular level. This will allow opthamologists to observe vascular structures in the eye that are often affected by certain diseases that impact vision. To avoid burning, the retinal camera is focused at the cone photoreceptor layer in the eye.

The rtx1 retinal camera system uses a flood illumination system for lighting. This illumination system is similar to those found in other cameras. However, flood illumination with cellular-level imaging allows the rtx1 to capture vascular patterns found in the eye. When combined with other diagnostic techniques, the rtx1 will allow opthamologists to quickly and easily diagnose a variety of eye diseases.

In prepared remarks, global communications director Mark Zacharria said, "The technology is protected by 4 proprietary patents." He continued, "These cover different aspects of the device's optical architecture that enable its superior image quality."

In addition to CE Mark approval in the European Union, the rtx1 received approval in Japan under the Shonin mark. The company hopes to receives FDA approval in mid-2013.