Given gets PillCam 510(k) clearance
Article Thumbnail ImageAugust 20, 2013 -- Video-capsule developer Given Imaging has received 510(k) clearance from the U.S. Food and Drug Administration for a new version of its camera-pill technology.

To get access to this article and all of the content on AuntMinnie.com, create a free account or sign-in now.

Member Sign In:
MemberID or E-mail Address:  
Do you have a AuntMinnie.com password?
No, I want a free membership.
Yes, I have a password:  



PillCam SB 3 is able to detect and monitor small-bowel abnormalities associated with Crohn's disease, obscure gastrointestinal bleeding, and iron deficiency anemia.

PillCam SB 3 provides a 30% improvement in image resolution compared to the firm's previous generations, with adaptive frame rate technology to deliver more-detailed small-bowel images and coverage, the firm said. In addition, PillCam SB 3's video processing engine has improved, and proprietary algorithms in the system's software enable video compilation that is 40% more efficient than PillCam SB 2, according to Given Imaging.

In July, the company reported that its PillCam Colon product has been cleared by Japan's Pharmaceuticals and Medical Devices Agency. PillCam SB 3 will be available in the U.S. beginning in the fourth quarter of 2013.