Kowa Optimed Receives 510(k) Clearance For Nonmyd™ WX^3D

Kowa Optimed, Inc.

Torrance, CA — Kowa Optimed, Inc., is part of a multi-faceted global company providing products and services to diverse markets, recently announced that they have received 510(k) approval from the U.S. Food and Drug Administration (FDA) for the marketing of their nonmydriatic 3D retinal camera, the nonmyd™ WX^3D, for simultaneous stereoscopic retinal photography. Kowa will immediately begin to market the diagnostic device in the USA and have scheduled formal launches at the 2011 Vision Expo East Show in New York and the American Society of Cataract and Refractive Surgery (ASCRS) in San Diego.

Kowa's latest product release, the nonmyd™ WX^3D Retinal Camera, adds the latest in Simultaneous Stereoscopic Photography (SSP) to their already integrated Normal and Small Pupil (SP) settings. With the addition of 3D photography of the optics disc, practitioners will be able to properly diagnose glaucoma in their patients. With the added ability to connect to Kowa's Digiversal™ Open Image Management system, managing information collected with the Kowa nonmyd™ WX^3D can be quickly viewed, compared, organized, annotated and shared.

Kowa nonmyd™ WX^3D Retinal Camera 2D and 3D Capable:
2D – Normal – Field Angle 45°

Kowa's exclusive optical design in combination with the 12-megapixel digital SLR camera delivers extremely detailed retinal images. The integrated 9-points internal fixation system allows for auto mosaic imaging covering a large retinal area.

Retinal images can be taken even with smaller pupils. On screen guides indicate if the pupil size is within the sufficient range (above 3.5mm) for photography.

Instant and simultaneous 3D imaging of the optic cup and disc is possible in a single shot. The Stereoscopic images are captured without image parallax shifts to strongly support glaucoma diagnosis.

"Kowa is committed to the advancement of health information technology within today's ophthalmic practice", states Dr. Ian Lane, EVP of Technology at Kowa Optimed. "By advancing innovation for eye care professionals through the institution of superb imaging technology, practitioners will, in turn, contribute to elevating the quality care for their patients."

About Kowa Optimed, Inc: Kowa Optimed, Inc. was founded in 1980 to provide a direct presence to the North and South American markets for Kowa's Electronics and Optics products. Kowa Optimed is a part of Kowa Company Ltd., which was founded in 1894. Kowa is one of the largest privately owned companies in Japan. In order to maintain a competitive advantage, Kowa has created highly successful divisions; Electronics & Optics Division, Pharmaceutical Division, Textile Division and the Non-Textile (General Merchandise) Division. For information, contact KOWA Optimed, Inc 20001 S. Vermont Avenue, Torrance, CA 90502, Phone: (800) 966-5692 or visit www.kowa-usa.com and click on new products.