Given Imaging Ltd. (GIVN)

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Given Imaging gets FDA nod to market RAPID 4 software system

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06.12.05 | 12:09 By Sharon Shpurer
Given Imaging (TASE, Nasdaq: GIVN) on Tuesday announced United States Food and Drug Administration approval to market a new, advanced software system.
The RAPID 4 software system is used to interpret the images of the noninvasive endoscopy images produced by the esophagal and small bowel PillCam. Given Imaging says it produces better results than the previous software versions.

The Yokneam-based company pioneered endoscopy of the digestive tract using a miniaturized camera in a capsule. It is swallowed by patients demonstrating gastric bleeding, or suspected of having Crohn's disease, for instance. The capsule then travels through the tract, sending images to a receiver worn on a belt (it looks like an MP3 player, Given Imaging says). It is then passed on naturally.



The images are interpreted using Given Imaging workstations armed with the company's software.
The new RAPID program 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, the company said.



"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."



The company said that RAPID 4's unique features include an automatic viewing mode, which helps doctors by regulating the rate of change so that images flow more smoothly and constantly.



It also has a "QuickView" mode, letting doctors scan the video and highlight images of interest. Yet another new feature is the "RAPID Atlas", Given Imaging says, which can proffer images stored in the database. The reference images can be searched by findings, diagnosis, or using Capsule Endoscopy Standard Terminology (CEST), the company says.



This year Given Imaging stock has lost 30% of its value, partly because it issued two earnings warnings in a row, and sank back to losses in the second quarter. Since October 20, though, its share price has appreciated by 10%.



In the third quarter Given Imaging was back in the black, reporting a $1.9 million profit or 7 cents per share on $19.8 million revenues, an increase of 36% from the same period of 2004.

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