FDA Clearance for Nidek CEM-530 Specular Microscope

The U.S. FDA has issued 510(k) Clearance for Nidek’s revolutionary new CEM-530 Specular Microscope that acquires images of the corneal endothelium and provides analysis very quickly and easily.

Background

In case you’re new to the company, Nidek is a Japanese company with a U.S. subsidiary in California. It specializes in research and development, design, manufacture and distribution of ophthalmic equipment.

 

Nidek’s CEM-530 Specular Microscope performs paracentral specular microscopy as well as collecting peripheral images. With its two-second auto analysis, automatic indication of the optimal image, 3-D auto tracking, auto shot, tiltable touch screen and built-in printer, image acquisition is both speedy and straightforward.

Paracentral images are captured at eight points, at a 5° visual angle within a 0.25mm x 0.55mm field and enable enhanced assessment surrounding the central image. Sixteen images are captured and automatically sorted based on quality.

Once the best image is selected, complete analysis is automatically performed in two seconds. The analysis screen allows visualization of the endothelial cells in four modes: trace, photo, area, and apex. This feature enables the clinician to verify analysis values with the corresponding cell images.

3-D auto tracking, auto shot, and tiltable touch screen provide ease of use, allowing faster and more accurate measurement. Nidek says that by using an LED light source this reduces power consumption, lasts longer, and saves on operational costs.

The CEM-530 can seamlessly integrate with most EMR systems without the need for an additional computer or software.

Company comments

Mr. Motoki Ozawa, President of NIDEK stated; “We are pleased to have this clearance, and confident the results reflect the quality of our diagnostic tools in corneal referencing and early diagnosis of endothelial disease.”

Source: Nidek, PR Web

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