Medeon Biodesign Receives FDA 510(k) Clearance for ClickClean(TM) - Laparoscope Lens Cleaning Device

Aug 25, 2015, 05:22 ET from Medeon Biodesign, Inc.

LOS ALTOS, Calif. and TAIPEI, Aug. 25, 2015 /PRNewswire/ -- 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. For more information, please visit www.medeonbio.com/en.

Contacts

Dr. Yi-Ju Chen
+886.2.2881.6686 
ir@medeonbio.com

SOURCE Medeon Biodesign, Inc.



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