News | May 16, 2007

Given Imaging Gains Clearance for Video Capsule, Software

May 17, 2007 - Given Imaging Ltd. today announced that it has received marketing clearance from the U.S. Food and Drug Administration (FDA) for its PillCam SB 2 video capsule and RAPID 5 software, which can be viewed at the Digestive Disease Week (DDW) 2007 in Washington, D.C. from 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 company's 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.