Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) has received US Food and Drug Administration (FDA) approval of the company's PillCam SB (small bowel) video capsule to monitor lesions that may indicate Crohn's disease.
The FDA approved the PillCam SB capsule in 2001 to view the small bowel mucosa and as a tool to detect abnormalities of the small bowel in adults and children from two years of age. The updated labeling reflects the expansive body of clinical data supporting the use of PillCam capsule endoscopy for the visualization of lesions in a variety of conditions, such as Crohn's disease, iron deficiency anemia and obscure gastrointestinal bleeding.
Dr. Blair Lewis at Mount Sinai Medical Center in New York said, "Previously physicians could use PillCam SB capsule endoscopy to detect Crohn's disease, and now we also can use this technology to monitor a patient's response to therapy to assure adequate healing. Studies have concluded that the use of PillCam SB in patients with inflammatory bowel disease, such as Crohn's disease, frequently changes the diagnosis, often resulting in a change in patient therapy, thereby underscoring the clinical impact of this tool."
Given Imaging's share price rose 5.1% in premarket trading on Nasdaq today to $19.91, giving a market cap of $565 million and rose 6.3% by mid-afternoon on the TASE to NIS 71.10.
Published by Globes [online], Israel business news - www.globes-online.com - on March 10, 2011
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