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Clearance for the Third Generation PillCam SB System in Japan

Mon, 09/23/2013 - 10:57am
Globe Newswire

News Continues Given Imaging's Series of Regulatory Successes During 2013

Given Imaging Ltd, a world leader in gastrointestinal medical devices and pioneer of capsule endoscopy, today announced that Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval for the PillCam SB 3 system. The innovative technology in this third-generation system will provide physicians throughout Japan, the world's second largest healthcare market, with the most advanced PillCam capsule endoscopy technology to detect and monitor small bowel diseases, such as Crohn's disease.

"Approval of the PillCam SB 3 system in Japan underscores our global commitment to providing physicians with innovative tools to detect and monitor abnormalities of the gastrointestinal tract," said Homi Shamir, President and CEO, Given Imaging. "The approval of the PillCam SB 3 system in Japan builds upon our recent regulatory momentum that includes PillCam COLON in Japan and PillCam SB 3 in the U.S. Japan is a critically important healthcare market and we look forward to working with physicians there to integrate PillCam SB 3's benefits into clinical practice."

Each component of the PillCam SB 3 system, including the capsule, recorder, sensor belt, and software, has been enhanced to work together to improve image quality, tissue coverage and efficiency. New adaptive frame rate technology also allows the capsule to automatically increase the rate at which images are taken when it senses it is moving more quickly through the digestive tract. Improvements in the new system's RAPID(R) for PillCam software enable even smarter video compilation which is 40% more efficient than with PillCam SB 21. The company expects to begin recognizing sales of PillCam SB 3 in Japan in 2014.

"With its higher resolution and improvement in capturing images of the small bowel mucosa, the new PillCam SB 3 capsule endoscopy system provides us with enhanced performance and efficiency," said Tetsuya Nakamura, M.D., Ph.D., Professor and Director, Department of Medical informatics, Dokkyo Medical University. "With these improvements, along with recently receiving an expanded indication, PillCam SB will continue to play an important role in the diagnosis and treatment of small bowel diseases in Japan."

Given Imaging will be participating in the upcoming Japan Digestive Disease Week (JDDW) conference taking place between October 9th -12th, 2013 in Tokyo. Company representatives will be available to share information about the newest features and capabilities of the PillCam SB 3 system along with Given Imaging's entire portfolio of gastrointestinal screening, diagnostic and monitoring products.

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