Healthcare Industry News: cataract
News Release - July 10, 2006
Visiogen's Barbara Niksch to Serve as Industry Representative on the FDA's Ophthalmic Devices Panel of the Medical Devices Advisory CommitteeIRVINE, Calif.--(HSMN NewsFeed)--July 10, 2006--Visiogen Inc. of Irvine today announced that its vice president of regulatory, quality and clinical affairs, Barbara A. Niksch, M.B.A., has accepted an appointment from the United States Department of Health & Human Services to serve as the industry representative on the FDA's Ophthalmic Devices Panel of the Medical Devices Advisory Committee. Her term begins immediately, and will continue through Oct. 31, 2009.
Selected by a committee of her peers in the medical device industry for her experience and leadership, Niksch will contribute to the panel by providing balanced recommendations based on her industry knowledge. As the industry representative, she will act on behalf of regulated industry at committee meetings. Niksch will present issues from the perspective of the affected industry and not as an individual from a specific sponsor. The panel consists of seven voting members with specific expertise in Ophthalmology and two non-voting members (the industry representative and the consumer representative).
Niksch is responsible for the worldwide regulatory, quality, and clinical research strategies and implementation activities at Visiogen Inc. Based in Irvine, Visiogen has developed the SynchronyŽ AIOL, a dual-optic accommodating intraocular lens and pre-loaded injector. The Synchrony AIOL recently received the CE Mark designation, and is currently undergoing clinical investigation in the United States.
Niksch has 17 years of experience working in the medical devices industry in the areas of ophthalmic and cardiovascular surgery. She has served on the board of directors for the Orange County Regulatory Affairs Discussion Group (OCRA) for the past six years and is currently the past president. Niksch is also an instructor within UC Irvine's Extension Program and is a member of the Regulatory Affairs Professional Society (RAPS) and the Association for Clinical Research Professionals (ACRP).
Visiogen Inc. is focused on developing innovative products for cataract and refractive patients. Founded in Irvine in 2001, Visiogen's first commercial application, SynchronyŽ, a dual-optic accommodating intraocular lens and pre-loaded injector, is currently in clinical studies in the U.S. and recently received the CE Marking in Europe.
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