Fremont, California (EastBayDaily) — NIDEK, a global leader in diagnostic and laser instrumentation for the eye care industry, announced today that the United States Food & Drug Administration (FDA) has issued 510K Clearance for its’ revolutionary new CEM-530 Specular Microscope that acquires images of the corneal endothelium and provides analysis very quickly and easily. The auto-tracking capabilities make acquisition speedy and straightforward.
Features include paracentral specular microscopy as well as peripheral images, two-second auto analysis, automatic indication of the optimal image, 3-D auto tracking, auto shot and a Tiltable touch screen and built-in printer
The 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 with the CEM-530. 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. The 3-D auto tracking, auto shot, and tiltable touch screen provide ease of use, allowing faster and more accurate measurement. An LED light source is utilized for illumination, which 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.
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.”
Founded in Gamagori, Japan in 1971, NIDEK continues to be a global leader in research and development, design, manufacture and distribution of ophthalmic equipment. The United States subsidiary based in Silicon Valley, California, provides sales and service for ophthalmic lasers, refractive lasers, and many advanced diagnostic devices.
For further information, contact:
Ms. Polly Neely, Senior Marketing Manager Phone: 800.223.9044 – ext. 762 E-mail: polly_neely(at)nidek(dot)com