09.23.13
Israeli company Given Imaging Ltd. has been granted approval by the Pharmaceuticals and Medical Devices Agency of Japan for its Pillcam SB 3 system. This is a third-generation version of a swallowable camera designed to detect and monitor the effects of small bowel disease such as iron deficiency anemia and obscure gastrointestinal bleeding caused by Crohn’s disease.
“Approval of the Pillcam SB3 system in Japan underscores our global commitment to providing physicians with innovative tools to detect and monitor abnormalities of the gastrointestinal tract,” said Homi Shamir, president and CEO Given Imaging. “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 United States. 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.”
The Pillcam SB 3 system is made up of components including the capsule, recorder, sensor belt, and software, which have reportedly been enhanced to work together to improve image quality, tissue coverage and efficiency. New adaptive frame rate technology also allows the capsule to automatically increase the rate at which images are taken when it senses it is moving more quickly through the digestive tract, the company claims. It is designed to transmit between two and six images per second. The software accompanying the device, called Rapid for Pillcam, is reportedly 40 percent more efficient than its previous iteration.
The original Pillcan SB was cleared by the U.S. Food and Drug Administration in 2001. Sale of the device in Japan are projected to begin next year.
The risks of Pillcam capsule endoscopy include capsule retention, aspiration and skin irritation. Endoscopic placement may present additional risks. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.
“With its higher resolution and improvement in capturing images of the small bowel mucosa, the new Pillcam SB 3 capsule endoscopy system provides us with enhanced performance and efficiency,” said Tetsuya Nakamura, M.D., Ph.D., professor and director of the department of medical informatics, Dokkyo Medical University. “With these improvements, along with recently receiving an expanded indication, Pillcam SB will continue to play an important role in the diagnosis and treatment of small bowel diseases in Japan.”
Given Imaging, based in Yoqneam, Israel, makes gastro intestinal imaging technology.
“Approval of the Pillcam SB3 system in Japan underscores our global commitment to providing physicians with innovative tools to detect and monitor abnormalities of the gastrointestinal tract,” said Homi Shamir, president and CEO Given Imaging. “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 United States. 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.”
The Pillcam SB 3 system is made up of components including the capsule, recorder, sensor belt, and software, which have reportedly been enhanced to work together to improve image quality, tissue coverage and efficiency. New adaptive frame rate technology also allows the capsule to automatically increase the rate at which images are taken when it senses it is moving more quickly through the digestive tract, the company claims. It is designed to transmit between two and six images per second. The software accompanying the device, called Rapid for Pillcam, is reportedly 40 percent more efficient than its previous iteration.
The original Pillcan SB was cleared by the U.S. Food and Drug Administration in 2001. Sale of the device in Japan are projected to begin next year.
The risks of Pillcam capsule endoscopy include capsule retention, aspiration and skin irritation. Endoscopic placement may present additional risks. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.
“With its higher resolution and improvement in capturing images of the small bowel mucosa, the new Pillcam SB 3 capsule endoscopy system provides us with enhanced performance and efficiency,” said Tetsuya Nakamura, M.D., Ph.D., professor and director of the department of medical informatics, Dokkyo Medical University. “With these improvements, along with recently receiving an expanded indication, Pillcam SB will continue to play an important role in the diagnosis and treatment of small bowel diseases in Japan.”
Given Imaging, based in Yoqneam, Israel, makes gastro intestinal imaging technology.