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Given Readies New Indications For PillCam And Prepares To Face Olympus

This article was originally published in The Gray Sheet

Executive Summary

Given Imaging expects to launch its PillCam Colon endoscopic capsule in the U.S. in 2007, which will help the firm contend with its first competitor, Olympus

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PillCam Colon passes EU

Given Imaging announces CE mark for the PillCam Colon Oct. 20. The firm plans to launch the ingestible video capsule following completion of more clinical trials underway in the U.S. and Europe. A three-center, 91-patient Israeli study showed that PillCam Colon identified 76% of polyps compared with 80% by colonoscopy, the current gold standard. Given anticipates filing for FDA clearance by year-end (1"The Gray Sheet" Nov. 14, 2005, p. 14). The firm's PillCam SB for the small intestine and PillCam ESO for the esophagus already are available in the U.S...

PillCam Colon passes EU

Given Imaging announces CE mark for the PillCam Colon Oct. 20. The firm plans to launch the ingestible video capsule following completion of more clinical trials underway in the U.S. and Europe. A three-center, 91-patient Israeli study showed that PillCam Colon identified 76% of polyps compared with 80% by colonoscopy, the current gold standard. Given anticipates filing for FDA clearance by year-end (1"The Gray Sheet" Nov. 14, 2005, p. 14). The firm's PillCam SB for the small intestine and PillCam ESO for the esophagus already are available in the U.S...

Olympus v. Given Imaging

Olympus files patent suit against Given's PillCam ingestible video capsule, charging that the device infringes a camera light source patent. Olympus acquired the patent from Boeing last July. Boeing had offered Given a license to the patent in 2002 but was turned down; Given argued against PillCam infringement. Olympus is seeking to compete against PillCam with its EndoCapsule; European trials are under way (1"The Gray Sheet" Nov. 14, 2005, p. 14)...

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