Capsule endoscopy pioneer Given Imaging (NASDAQ:GIVN; Yoqneam, Israel) has received FDA clearance for its next generation PillCam SB 3 to detect and monitor small bowel abnormalities associated with Crohn's disease, obscure gastrointestinal 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, according to the company. Its video processing engine has been significantly improved and proprietary algorithms in the system's new software enable smarter video compilation that is 40 percent more efficient than PillCam SB 2, they claim.
FDA clearance for PIllCam SB 3 represents the second regulatory milestone for the company in 2013; in July, they reported that PillCam COLON has been cleared by Japan's Pharmaceuticals & Medical Devices Agency.
PillCam SB 3 will be available in the U.S. beginning in the fourth quarter of 2013.
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