FDA approves PillCam SB3 for imaging in the GI tract

The FDA has granted 510(k) clearance for the next generation miniature video device PillCam SB 3, from Given Imaging, to detect and monitor small bowel abnormalities associated with Crohn's Disease, obscure gastrointestinal (GI) bleeding and iron deficiency Anemia.

The PillCam SB 3 capsule is a minimally invasive procedure to visualize and monitor small bowel abnormalities, and measures 11 mm x 26 mm and weighs less than four grams. Now in its third generation, PillCam SB 3 contains an imaging device and light source and transmits images at a rate between two and six images per second.