Nidek announced that the FDA has issued 510(k) clearance for the manual analysis function for the CEM-530 Specular Microscope. This feature will enable practitioners to analyze cells manually that are not identified by the auto-analysis function due to poor image quality.
The CEM-530 Specular Microscope can be upgraded to manual analysis function by a software upgrade. The center point manual analysis is initiated by selecting the approximate center of a cell. Adjoining cells are then detected based on the surrounding points. This method is particularly effective for areas where groups of cells are clumped together. The versatility of automated and manual analysis allows speed and precision.