Given Imaging Ltd. (GIVN)

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Given Imaging Receives FDA Clearance of New Advanced Software
Monday December 5, 4:06 pm ET
- RAPID 4 for PillCam(TM) SB and ESO Facilitates More Efficient Reading and Improved Diagnostic Confidence -


YOQNEAM, Israel, Dec. 5 /PRNewswire-FirstCall/ -- Given Imaging (Nasdaq: GIVN - News) announced today that it received clearance from the U.S. Food and Drug Administration to market the most advanced version of its patented RAPID(TM) software, RAPID 4, for use with the PillCam(TM) Platform. RAPID 4 offers new features and powerful diagnostic tools that aid in the reading and interpretation of the videos captured from the PillCam SB and PillCam ESO capsules.
"RAPID 4 demonstrates our global leadership in developing proprietary software solutions that enable physicians to manage their patients far more efficiently than ever before," said Gavriel D. Meron, president and CEO of Given Imaging. "We firmly believe that this new platform will support both the expansion of our installed base, together with increased utilization by our existing customer base worldwide."


RAPID 4's new and unique features include:

-- Automatic Viewing Mode: Aids in more efficient diagnostic review of the
video by regulating the rate of change so that images flow more
smoothly and constantly.

-- QuickView: Allows fast preview of the video and highlights potentially
interesting images in the video stream.

-- RAPID Atlas: Compares the on-screen case image with known reference
images stored in the database. The reference images can be searched by
findings, diagnosis, or using Capsule Endoscopy Standard Terminology
(CEST).

The PillCam Platform includes three components:

-- The Given Workstation: Equipped with Given's proprietary RAPID
Application Software which processes the data and produces a video of
the GI tract. The software allows physicians to view the video, save
individual images and short video clips, compare captured images to
those stored in the RAPID Atlas, save the findings, and then write,
edit, and print reports.

-- PillCam SB and PillCam ESO Video Capsules: Disposable miniature video
cameras contained in a capsule that are ingested by the patient. Once
swallowed, the capsule passes naturally through the digestive tract,
transmitting high quality color images of the patient's small bowel or
esophagus.

-- The DataRecorder 2: Similar to a personal MP-3 player, this is worn
around the patient's waist to receive and record signals transmitted by
the PillCam video capsule as it passes through the digestive track.
Patients can normally continue their daily activities during the
examination.

About Given Imaging
Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company is developing a complete line of PillCam(TM) video capsules for detecting disorders of the gastrointestinal tract. The company's technology platform is the Given® Diagnostic System, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient. The PillCam(TM) SB capsule is the only naturally ingested method for direct visualization of the entire small intestine. It is currently marketed in the United States and in more than 50 other countries and has benefited more than 260,000 patients worldwide. The PillCam(TM) 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. For more information, visit http://www.givenimaging.com.

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