Given Imaging Announces Marketing Clearance for 14 Frame PillCam ESO Video Capsule for the Esophagus.YOQNEAM, Israel -- Given Imaging (Nasdaq: GIVN), the global leader in capsule endoscopy Capsule Endoscopy is a term used to describe a miniature capsule used to record images through the digestive tract for use in medicine. It was developed by an Israeli missile specialist in the mid-1990's. , today announced that it received marketing clearance from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for the 14 frame PillCam(TM) ESO ESO European Southern Observatory ESO Educación Secundaria Obligatoria (Spain: compulsory secondary education) ESO European Organisation for Astronomical Research in the Southern Hemisphere ESO Edmonton Symphony Orchestra video capsule for visualization of the esophageal mucosa together with the new RAPID 3 software that includes numerous features and enhancements. Given Imaging will immediately begin marketing and selling the new RAPID3 software, upgrading eligible customers , and delivering PillCam ESO to market. With this FDA clearance, Given Imaging will receive the first milestone payment from Ethicon Endo-Surgery Ethicon Endo-Surgery, Inc., a subsidiary of Johnson & Johnson, is a company that designs and manufactures medical devices and surgical instruments with the intent of minimizing the invasiveness of surgery. Ethicon Endo-Surgery was part of Ethicon, Inc. amounting to $10 million . This amount will be recorded on a straight line over the 15 year life of the agreement as a reduction in marketing expenses. 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 video capsules for detecting disorders throughout the gastrointestinal tract gastrointestinal tract n. The part of the digestive system consisting of the stomach, small intestine, and large intestine. Gastrointestinal tract . The company's technology platform is the Given(R) Diagnostic System, featuring the PillCam(TM) video capsule, a disposable, miniature video camera contained in a capsule, which is ingested in·gest tr.v. in·gest·ed, in·gest·ing, in·gests 1. To take into the body by the mouth for digestion or absorption. See Synonyms at eat. 2. by the patient. The PillCam(TM) SB video capsule is the only naturally ingested method for direct visualization of the entire small intestine small intestine Long, narrow, convoluted tube in which most digestion takes place. It extends 22–25 ft (6.7–7.6 m), from the stomach to the large intestine. . It is currently marketed in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. and in more than 60 other countries and has benefited more than 145,000 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 Tokyo, Madrid and Sydney. For more information, visit http://www.givenimaging.com. This press release contains forward-looking statements about Given Imaging, including projections about our business, our future revenues and our future profitability, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, statements in the future tense future tense n. A verb tense expressing future time. Noun 1. future tense - a verb tense that expresses actions or states in the future future , words such as "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance used in connection with any discussion of future operating or financial performance identify such forward-looking statements. Those forward- looking statements are not guarantees of future performance and actual results could differ materially from our current expectations as a result of numerous factors, including but not limited to the following: changes in regulatory environment, our success in implementing our sales, marketing and manufacturing plan, protection and validity of patents and other intellectual property rights, the impact of currency exchange rates, the effect of competition by other companies, the outcome of future litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , the reimbursement policies for our product from healthcare payors, quarterly variations in operating results, the possibility of armed conflict or civil or military unrest in Israel and other risks disclosed in our filings with the U.S. Securities Exchange Commission. |
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