Gastrointestinal diagnostic products company Given Imaging Ltd. (GIVN), Thursday said the U.S. Food and Drug Administration recently cleared its PillCam SB video capsules and Agile patency capsules for use in patients two years of age and above.
PillCam capsule endoscopes are ingestible video capsules that enable physicians to visualize distinct portions of the GI tract. Given Imaging's products use wireless technology and advanced software to enable gastroenterologists to diagnose diseases of the esophagus, small bowel and colon and more accurately treat patients.
Previously, PillCam SB and Agile were indicated for children of 10 years and older. Given Imaging said the PillCam SB is cleared for the visualization of the small bowel mucosa and may be used as a tool for the detection of abnormalities of the small bowel now.
PillCam SB helps in the evaluation of small bowel abnormalities, such as obscure GI bleeding, iron deficiency anemia, suspected Crohn's disease, suspected small intestinal tumors, polyposis syndromes, as well as in suspected or refractory malabsorptive syndromes, such as celiac disease.
Given Imaging said studies have indicated that only with capsule endoscopy could the small bowel be sufficiently visualized for a diagnosis and treat underlying cause of their symptoms. Given Imaging said clinical trials showed that PillCam capsule endoscopy can help bring value to very young patients in need of small bowel evaluation.
GIVN is trading at $14.62, down $0.29 or 1.94%, on the Nasdaq.
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