A Medical Device Daily

Given Imaging (Yoqneam, Israel) reported receiving FDA clearance for its PillCam SB 2 video capsule and RAPID 5 Software.

Given said that the video capsule offers advanced optics and a wider field of view for imaging the small bowel. It has the same dimensions as Given'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 Given's next generation of PillCam video capsules including PillCam SB 2, PillCam COLON and PillCam ESO 2, with the last two 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 allows fast preview of PillCam video images and identifies images that may be of interest to the reviewer; The Lewis Score, which provides an approximate measure of mucosal damage.

Combined with other clinical parameters such as patient history and previous diagnostics, the Lewis Score can be used to monitor the progress of patient treatment; RAPID Atlas which enables the side-by-side comparison of case images with a searchable database of peer-reviewed reference images; and colon track which indicates where the PillCam COLON video capsule is located.