FDA Clears Given Imaging’s Swallow-able Camera

Israeli company Given Imaging Ltd. has been granted 510(k) clearance from the U.S. Food and Drug Administration for its next-generation Pillcam SB3, a swallow-able camera designed to detect and monitor small bowel abnormalities associated with Crohn’s disease, obscure gastrointestinal (GI) bleeding and iron deficiency anemia.

“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 U.S. and across the globe,” said Homi Shamir, president and CEO of Given Imaging. “We believe Pillcam SB3 will both enhance the clinical experience for our large base of existing U.S. customers and expand the market for this product among new physicians who have not been performing Pillcam procedures.”

The Pillcam SB3 has been designed as an upgrade to its previous iteration, the SB. According to the company, it has a 30 percent improvement in image resolution with adaptive frame rate technology to deliver more detailed small bowel images and coverage; an improved video processing engine; and smarter video complication enabled by proprietary algorithms that are reportedly 40 percent more efficient.

“Patients with complicated diseases involving the small bowel, such as Crohn’s disease, often struggle to comprehend what is happening inside their bodies and how it can be better managed,” said Felice H. Schnoll-Sussman, M.D., director of the Jay Monahan Center for Gastrointestinal Health, New York-Presbyterian Weill Cornell Medical Center. “The improved image resolution and overall efficiency of the Pillcam SB 3 system in capturing and analyzing images of the small bowel has potential to have a meaningful impact on patient care.”

“Our goal as we set out to reimagine and improve the Pillcam platform was not just to provide physicians with more information, but to provide them with better and more actionable information,” said Shamir. “By delivering more detail, more coverage and improving the overall efficiency of our technology platform, we have achieved this with Pillcam SB3.

Clearance for the Pillcam SB3 is the second regulatory milestone this year for Given Imaging. In July, Japan’s Pharmaceuticals & Medical Devices Agency cleared Pillcam Colon for commercialization. Pillcam SB3 will be available for in the United States at the beginning of October.

Give Imaging’s U.S. headquarters are in Duluth, Ga. The company makes imaging technology for gastrointestinal health.