Given Imaging Gets FDA Nod for PillCam SB, Plans for Big Q4

August 21, 2013

The third generation of Given Imaging‘s PillCam SB got FDA approval today, and President and CEO Homi Shamir said the product should launch in October of this year. The device, a capsule with a camera inside which the patient swallows takes more than 60,000 images before it exits the digestive system. As the Israel-based continues to attempt to penetrate the Crohn’s market, the device is meant to offer Crohn’s patients, who often develop small lesions on the small bowel, with less invasive options than endoscopy. The FDA has also approved it to detect small bowel abnormalities in patients with obscure GI bleeding and iron deficiency anemia.

This generation improves upon the last with higher-res images and a more user-friendly software system, plus it should only take the physician about 30 minutes to download and read the results.The new PillCam SB will use the same reimbursement indication as before, Shamir said.

This, coupled with the company’s anticipated FDA approval of PillCam COLON (a smartpill that takes the place of colonoscopy recently approved for use in Japan and Europe) later this year, is why Shamir is excited for Q4 this year. It bodes well for the company, which Shamir said already has a 95 percent market share in capsule endoscopy.
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