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Given Imaging Announces FDA Clearance of Capsule Endoscopy for Pediatric Use

Yoqneam, Israel – November 5, 2003 – Given Imaging (NASDAQ: GIVN) announced

today that the FDA has cleared capsule endoscopy for pediatric use in children

ages 10 -18, effective October 29, 2003.

FDA Clearance was based on a 30-patient study conducted by Ernest G. Seidman,

M.D., Chief, Division of Gastroenterology, at Sainte-e Hospital in

Montreal. The study was a comparative, prospective self-controlled trial of

pediatric patients suspected of having Crohn's disease, intestinal polyposis, or

occult or obscure GI bleeding.

The study concluded that capsule endoscopy diagnosed or definitively excluded a

bleeding source, small bowel polyps or Crohn's disease in twenty-nine of thirty

patients studied. The capsule was well tolerated in all patients with no adverse

symptoms.

" Clearance of the Given System for pediatric use means that Gastroenterologists

will now be able to utilize capsule endoscopy for non-invasive visualization of

the small intestine in this patient segment. That will provide a higher

diagnostic yield while eliminating unnecessary sedation, radiation, risks and

trauma associated with invasive procedures, including scoping and exploratory

surgery, " said Gavriel D. Meron, President and CEO of Given Imaging.

“Capsule endoscopy is a safe, effective and compassionate method for diagnosing

small bowel disorders in children. We have seen many cases of patients who

suffered from undetected small bowel disorders and, after ingesting the capsule,

received a definitive diagnosis and subsequent treatment which significantly

improved their lives”, said R. Treem, MD, Chief of Pediatric

Gastroenterology and Nutrition, Duke University. “In one case, a young girl

suffered for months with severe abdominal pain and bleeding, and underwent

numerous invasive tests with no diagnosis. She subsequently ingested the M2A

capsule and was diagnosed with Crohn’s disease. Today, her condition is under

control and she is living the normal life of a teenager. I believe that capsule

endoscopy should be a first line diagnostic tool for children with suspected

small bowel disorders.”

Study results were presented at Digestive Disease Week 2003 last May in Orlando,

Florida.

About Given Imaging

Given Imaging develops, produces and markets the Given® Diagnostic System

featuring the M2A® Capsule Endoscope, the only non-invasive method for direct

visualization of the entire small intestine. The system uses a disposable

miniature video camera contained in a capsule which is ingested by the patient.

The M2A® capsule passes naturally through the digestive tract, transmitting high

quality color images, without interfering with the patient's normal activities.

The system received clearance from the FDA in August 2001 and received

permission to affix the CE mark in May 2001. Distribution channels for the

system have been established in more than 50 countries worldwide. The M2A®

capsule has been utilized to diagnose a range of diseases of the small intestine

including Crohn's Disease, Celiac disease and other malabsorption disorders,

benign and malignant tumors of the small intestine, vascular disorders,

medication related small bowel injury, as well as a range of pediatric small

bowel disorders. For more information, visit 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, 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, 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.

Mark E. Armstrong

NW Rep, PAI

www.top5plus5.com

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