News | May 16, 2007

FDA Clears PillCam SB 2 Endoscope, RAPID 5 Software

May 17, 2007 - Given Imaging Ltd. today announced that it has received marketing clearance from the FDA for its PillCam SB 2 video capsule, its our next generation small bowel video capsule, and RAPID 5 Software, an upgraded version, which it will debuted at Digestive Disease Week (DDW) 2007, in Washington, D.C., May 19-24.

The PillCam SB 2 video capsule offers advanced optics and a wider field of view for imaging the small bowel. It has the same dimensions as the Company’s flagship PillCam SB and captures nearly twice the mucosal area per image compared to PillCam SB. PillCam SB 2 also provides automatic light control for optimal illumination of each image.

RAPID 5 supports the next generation of PillCam video capsules, including PillCam SB 2, PillCam COLON and PillCam ESO 2, with the last two still pending FDA clearance. The software includes new tools to improve a physician's reading efficiency of PillCam endoscopy videos and increase diagnostic confidence. New RAPID 5 features include: QuickView v5, which reportedly allows fast preview of PillCam video images and
identifies images that may be of interest to the reviewer; the Lewis Score, an approximate measurement of mucosal damage and used to monitor the progress of patient treatment; RAPID Atlas, a side-by-side comparison of case images with a searchable database of peer-reviewed reference images; Colon Track, which indicates where the PillCam COLON video capsule is located.

The PillCam SB 2 video capsule and RAPID 5 Software will be available for shipment to customers in the second half of 2007.

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