-New Orleans, LA, USA, November 6, 2001-
NIDEK, Inc. and NIDEK Technologies America announced today that the U.S. Food and Drug Administration has granted 510(k) clearance for the ConfoScan Confocal Microscope. NIDEK's ConfoScan is a state-of-the-art fully digital corneal confocal microscope.
The ConfoScan allows corneal specialists, refractive surgeons and ophthalmologists to quickly record digital images of in-vivo corneal layers. ConfoScan utilizes digital recording software to examine the many layers of the eye at the cellular level, graphically displaying images for fast and quick review. ConfoScan can be used for pre operative assessment of corneal health; diagnose early signs of keratoconus and dry eye, as well as indicating overall endothelial viability, measuring flap depth, interface healing quality, and epithelial layer analysis.
"The importance of the ability to see the cornea on a cellular level cannot be overstated," states Philip Buscemi, O.D., Vice President and General Manager of NIDEK Technologies America. "The Clinical and cost effectiveness of the ConfoScan is making confocal microscopy the standard of care for corneal specialists. "
ConfoScan is the latest in confocal microscopes developed by NIDEK Technologies Srl. With this newest addition to the family, the ConfoScan is significantly smaller, offers more integrated features in an 'all in one' tabletop box. Most markedly, the ConfoScan's ease of use has been dramatically increased in the re-design.
To date, NIDEK Technologies America is the only supplier of the fully digital confocal microscope in the United States.
Based in Greensboro, North Carolina, NIDEK Technologies America is a wholly owned subsidiary of NIDEK, Co., Ltd. of Gamagori, Japan.
NIDEK Technologies America, formerly known as Fortune Technologies America, a technology incubator for NIDEK Co., distributes advanced instruments and software for ophthalmology and optometry developed by NIDEK Technologies Srl. that allow integration of data from various high technology instruments to be incorporated into one database. NIDEK Technologies America employs world-class experts in the development of software applications that are used by ophthalmic equipment to acquire and process images and data. Among NIDEK Technologies America's accomplishments is the development of software that automatically classifies and statistically analyzes corneal cell imagery; corneal topography software; and both retinal and anterior segment digital imagery applications.
For additional information, please visit http://www.nidektech.com
