Given Imaging Gets FDA Clearance For Next Generation PillCam SB 3 - Quick Facts

(RTTNews) - Medical diagnostics company Given Imaging Ltd. (GIVN) said the United States Food and Drug Administration or FDA has granted 510(k) clearance for the next generation PillCam, SB 3, to detect and monitor small bowel abnormalities associated with Crohn's disease, obscure gastrointestinal or GI bleeding and iron deficiency anemia.

The PillCam SB 3 system combines a 30% improvement in image resolution with adaptive frame rate technology to deliver more detailed small bowel images and coverage. Further, PillCam SB 3's video processing engine has been improved significantly. Proprietary algorithms in the system's new software enable even smarter video compilation that is 40% more efficient than PillCam SB 2.

PillCam SB 3's U.S. clearance represents the second regulatory milestone for Given Imaging in 2013. In July, the firm said PillCam COLON has been cleared by Japan's Pharmaceuticals & Medical Devices Agency. PillCam SB 3 would be available in the U.S. beginning in the 2013 fourth quarter.