Given Imaging receives FDA clearance for new software
The capsule endoscopy platform's new features include smoother video image flow, fast preview, and a medical atlas.
Globes correspondent 6 Dec 05 09:55
Given Imaging (Nasdaq: GIVN; TASE: GIVN) has announced that it received clearance from the US Food and Drug Administration (FDA) to market the newest version of its patented RAPID software, RAPID 4, for use with the PillCam capsule endoscopy platform. The PillCam platform comprises three parts: disposable miniature video cameras contained in a capsule that are ingested by the patient, then pass naturally through the digestive tract, transmitting high quality color images of the patient's small bowel or esophagus; a data recorder worn around the patient's waist to receive and record signals transmitted by the video capsule as it passes through the digestive track, while patients continue their normal daily activities; and the workstation, equipped with RAPID software that processes the data and produces a video of the GI tract.
Given Imaging stated that RAPID 4 offers new features and powerful diagnostic tools that aid in the reading and interpretation of the videos captured. The new features include an automatic viewing mode, which aids in more efficient diagnostic review of the video by regulating the rate of change so that images flow more smoothly and constantly; a fast preview feature that highlights potentially interesting images in the video stream; and an atlas feature that compares the on-screen case image with known reference images stored in the database.
Given Imaging is developing a complete line of PillCam video capsules for detecting disorders of the gastrointestinal tract. The PillCam SB capsule is the only naturally ingested method for direct visualization of the entire small intestine. It is currently marketed in the US and in more than 50 other countries. The PillCam ESO video capsule, which provides visual examination of the esophagus, has been cleared for marketing by the FDA. Additional capsules for visualization of the stomach and colon are under development.
Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel; it has direct sales and marketing operations in the United States, Germany and France, and local offices in Japan, Spain and Australia.
Published by Globes [online], Israel business news - www.globes.co.il - on Tuesday, December 06, 2005
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