Given Imaging, a manufacturer of gastrointestinal medical devices, has obtained an approval from the Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for its third-generation PillCam SB 3 system, which can detect small bowel abnormalities related to Crohn's disease and gastrointestinal bleeding.
Weighing less than 4g, the 11mm by 26mm video capsule features an imaging device and a light source that can transmit anywhere between two and six images in one second.
Due to software enhancements, the PillCam SB 3 offers a 40% more efficient video compilation than the earlier SB 2 version.
Given Imaging president and CEO Homi Shamir noted approval of the PillCam SB 3 system in Japan underscores the company’s global commitment to provide physicians with innovative tools to detect and monitor abnormalities of the gastrointestinal tract
"The approval of the PillCam SB 3 system in Japan builds upon our recent regulatory momentum that includes PillCam COLON in Japan and PillCam SB 3 in the U.S. Japan is a critically important healthcare market and we look forward to working with physicians there to integrate PillCam SB 3’s benefits into clinical practice," Shamir added.
The company anticipates beginning sales of PillCam SB 3 system in Japan in 2014.