益安：Medeon Biosurgical腹腔鏡影像清晰器材獲FDA產品上市許可 2015/08/21 15:35 證交所重大訊息公告(6499)益安-代公告本公司之孫公司Medeon Biosurgical, Inc.之腹腔鏡影像清晰器材(LAP-A01)醫療器材「Laparoscope Lens Shield Device」獲美國食品藥物管理局(FDA)510(k)產品上市許可。1.新產品開發完成日期:104/08/21 2.新產品內容:腹腔鏡影像清晰器材(LAP-A01)「Laparoscope Lens Shield Device」可使外科醫師在手術進行中，迅速於原位清潔鏡頭髒污、快速回復影像清晰品質。 3.對公司財務、業務之影響:腹腔鏡影像清晰器材(LAP-A01)「Laparoscope Lens Shield Device」取得美國食品藥物管理局(FDA)510(k)醫療器材查驗登記許可，亦即取得在美國境內銷售資格，對本公司財務、業務將有正面影響。 4.其他應敘明事項:本產品及智慧財產權係由孫公司Medeon Biosurgical, Inc. 持有，並委由本公司全權進行產品研發並申請FDA產品上市許可。
Medeon Biodesign Receives FDA 510(k) Clearance for ClickClean Laparoscope Lens Cleaning Device Los Altos, CA and Taipei -- Medeon Biodesign, Inc., a Taiwan medical device company, is pleased to announce that the company has received U.S. Food and Drug Administration 510(k) clearance for ClickClean, a lens cleaning device. ClickClean provides instant, in-situ, one-click lens cleaning during laparoscopic procedures, which virtually eliminates the need to remove the laparoscope from the body cavity during surgery and significantly reduces the total time, cost, risks and repeated frustration associated with maintaining a clear visual field. "Impaired vision due to a soiled lens routinely occurs in nearly every surgery. A soiled lens is one of the disadvantages and most prominent frustrations in performing laparoscopic surgery," said Dr. Thomas Hsu, the original inventor of ClickClean and an urologist at Kaiser Permanente Santa Clara Medical Center, California as well as a Consulting Professor of Urology at Stanford University School of Medicine. "Based on its elegant design to achieve easy and instant lens cleaning, ClickClean could eliminate nearly all of the surgical delays, risks and frustrations associated with existing techniques for laparoscopic lens cleaning." "ClickClean is a single-use, disposable accessory for laparoscopic surgery, which uses a transparent film to shield the lens from blood, fat, smoke and debris during the surgery by simply clicking a trigger on the device and immediately replacing the soiled film with a segment of new and clean film. It is estimated that 2.8 million laparoscopic procedures are performed in the US and approximately 7.5 million procedures are performed worldwide each year. ClickClean addresses the unmet need of virtually every laparoscopic surgery," says Dr. Yue-Teh Jang, CEO of Medeon Biodesign.
About Medeon Biodesign Medeon Biodesign is a publicly traded company located in Taipei, Taiwan, and currently listed on the Emerging Stock Board of the Taipei Exchange. The company focuses on the development of medical devices for minimally invasive surgeries to treat diseases of sizable patient population, such as cardiovascular, peripheral vascular, orthopedic, neurosurgery, obesity, gastroenterology, hematology, nephrology, gynecology, urology, and plastic surgery. Medeon Biosurgical, Inc., which owns the ClickClean product and its intellectual properties, has contracted the parent company, Medeon Biodesign, to develop and obtain this 510(K). Medeon Biosurgical, is a Cayman registered medical device IP holding company. SOURCE: PR Newswire
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