US FDA Approves Use of Latest Israeli Invented PillCam to Monitor Crohn’s Disease
by Joshua Levitt
Sufferers of Crohn’s and other diseases, including obscure gastrointestinal (GI) bleeding and iron deficiency anemia, will benefit from the US Food and Drug Administration’s 510(k) clearance Tuesday of the next generation PillCam, SB 3, created by Israeli capsule endoscopy developer Given Imaging, which is listed on the Tel Aviv and Nasdaq stock exchanges. The new cameras will be marketed in the US starting in the fourth quarter of this year.
In a statement, Given Imaging president and CEO Homi Shamir said, “With more than 2 million procedures conducted since the first generation of the product was introduced, PillCam SB has had a significant impact on patient care in the US and across the globe. We believe PillCam SB 3 will both enhance the clinical experience for our large base of existing US customers and expand the market for this product among new physicians who have not been performing PillCam procedures.”
On the company’s website, Given Imaging notes that 75% of Crohn’s patients have lesions in their small bowel that can be better assessed using its camera technology. In findings, within three months of using the PillCam doctors changed the treatment for 62% of patients and 40% were prescribed new medication.
The new system offers a 30% greater image resolution that delivers more detailed small bowel images and coverage, Given Imaging said.