FDA News

NIDEK Gains FDA Clearance for ORION, a New Auto-Retinal Imaging Device

(April 29, 2007)--NIDEK, speacialist in laser and diagnostic instrumentation for the optical and eye care industry, announced today that the U. S. Food & Drug Administration (FDA) has approved the first product of the AutoEase' line called ORION, an Auto-Retinal Imaging device for use in screening patients for retinal diseases such as diabetic retinopathy and AMD.

With this approval, ophthalmologists, optometrists and family physicians are able to identify retinal diseases in patients and refer them to a retinal specialist for further diagnosis and treatment.

With its ease of use as an Auto-Retinal Imaging device, ORION enables patients to screen their retina without the assistance of a technician. The primary method of operation behind ORION includes a voice synthesizer. The voice prompts the patient through the screening process and captures a 7 micron, high resolution image of the patient's retina, which can be electronically sent to a retinal specialist for further diagnosis. In addition, ORION can screen both retinas of a patient in less than 2 minutes.

Mr. Motoki Ozawa, Vice President, NIDEK stated, "ORION is a perfect addition to NIDEK's strong, world-class product portfolio in unsurpassed diagnostic and surgical instrumentation, optical finishing and dispensing products in vision care.

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