Given Imaging pioneered the capsule endoscopy technology and has also developed capsule-based pH monitoring.[1] Through Sierra Scientific Instruments, a subsidiary, Given Imaging also provides an array of diagnostic modalities including high-resolution manometry and ambulatory reflux monitoring. Given Imaging's technology is currently marketed in over 60 countries.
History
Given Imaging was founded in 1998 by Gavriel Meron and Rafael Development Corporation (RDC) Ltd. based on the purchase of an early patent from Rafael Advanced Defense Systems Ltd. Initial funding for the company was provided by Elron Electronic Industries, Israel's leading technology holding company, in cooperation with Rafael. Today, Elron still holds 28% Given Imaging's shares.[2] The idea for the solution was developed by Dr. Iddan, while working in the missile division of Rafael, where he envisioned that missile technology could be miniaturized to create a medical product.[3]
The company's first capsule endoscopy products was named M2A capsule and received it CE marking in May 2001 and in August 2001 was cleared
by the US Food and Drug Administration (FDA) for visualization of abnormalities of the small intestine[4] The capsule uses a radio developed for Given by Zarlink Semiconductor's medical team in San Diego and Jarfalla, Sweden.
In October 2001, Given Imaging had an Initial public offering on NASDAQ under ticker GIVN.)[5] In September 2004, M2A capsule re-branded PillCam SB(R).
In November 2004, US FDA clears PillCam(R) ESO for the esophagus
In May 2006, US FDA clears Agile Patency System[7]
In October 2006, PillCam COLON was cleared for marketing in the European Union (CE Mark)[8]
In December 2008, Given Imaging acquired Bravo pH Monitoring System(R)
In May 2009, 1 millionth PillCam capsule was sold[9]
In September 2009, PillCam COLON 2 receives CE Mark[10]
In July 2012, Given Imaging's capsule endoscopy featured in a live broadcast on the BBC, when the reporter Michael Mosley spent the day as an exhibit at the Science Museum in London, after swallowing a PillCam which transmitted live pictures to a public screen.[11]
In February 2014, 100% of Given Imaging's shares were purchased by Covidien, making it a Private Company fully owned by Covidien. As a result, its shares are no longer traded neither in NASDAQ nor in TASE[12]
PillCam SB is a tool for visualization of the entire small bowel and detection of small bowel abnormalities. No sedation is needed, however bowel prep is needed. A liquid bowel prep is consumed before the procedure emptying the bowel completely, this allows clear photos to be taken.[13]
PillCam ESO
PillCam ESO provides a method for visualization of the esophagus.[14]
PillCam COLON 2
PillCam COLON 2 is complementary to traditional colonoscopy and is used for patients who have received incomplete colonoscopy, are contraindicated for colonoscopy or are unwilling to undergo traditional colonoscopy.[citation needed]
PillCam CROHN'S
The PillCam CROHN’S system offers direct visualization of the entire small bowel and colonic mucosa with a noninvasive procedure.
PillCam Express
In May 2010, Given Imaging released a new manually guided GI scope based on PillCam swallowable devices. In cases where patient anatomy does not allow for natural passage of large tablets the size of traditional PillCams, the PillCam Express can be delivered through the stomach and into the small intestine with help of an endoscope and a proprietary balloon deployment mechanism.[15]
Bravo pH Monitoring System
The Bravo pH Monitoring System is a catheter-free ambulatory pH test.[16] Ambulatory pH testing is considered the gold standard for pH measurement and monitoring of gastric reflux, helping clinicians manage gastroesophageal reflux disease (GERD). Featuring data collection for up to 96 hours, Bravo allows patients to maintain their regular diets and activities, accurately reflecting normal physiologic conditions.[citation needed]
Sierra Scientific Instruments
In April 2010, Given Imaging acquired Sierra Scientific Instruments.[17]
Given Imaging's wholly owned subsidiary, Sierra Scientific Instruments, is located in Los Angeles, California, with manufacturing operations in Vietnam.[citation needed]
^The accuracy of PillCam ESO capsule endoscopy versus conventional upper endoscopy for the diagnosis of esophageal varices: a prospective three-center pilot study. Endoscopy. 2006;38(1):1-5. 20. Eliakim R, Fireman Z, Gralnek IM, Yassin K, Waterman M, Kopelman Y, Lachter J, Koslowsky B, Adler SN. Evaluation of the PillCam Colon capsule in the detection of colonic pathology: results of the first multicenter, prospective, comparative study. Endoscopy. 2006 Oct;38(10):963-70.