Capsule endoscopy developer Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the next generation PillCam, SB 3, which detects and monitors small bowel abnormalities associated with Crohn's disease, obscure gastrointestinal (GI) bleeding and iron deficiency anemia.
Given Imaging president and CEO Homi Shamir said, "With more than 2 million procedures conducted since the first generation of the product was introduced, PillCam SB has had a significant impact on patient care in the US and across the globe. We believe PillCam SB 3 will both enhance the clinical experience for our large base of existing US customers and expand the market for this product among new physicians who have not been performing PillCam procedures."
Given Imaging said that the PillCam SB 3 system combines a 30% improvement in image resolution with adaptive frame rate technology to deliver more detailed small bowel images and coverage. PillCam SB 3's video processing engine has also been significantly improved. Proprietary algorithms in the system's new software enable even smarter video compilation that is 40% more efficient than PillCam SB 2.
PillCam SB 3 will be marketed in the US starting in the fourth quarter.
Published by Globes [online], Israel business news - www.globes-online.com - on August 13, 2013
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