Given Imaging’s PillCam SB 3 video capsule receives 510(k) clearance

12 August 2013 (Last Updated August 12th, 2013 18:30)

Israel-based medical devices developer Given Imaging has got clearance from the US regulatory agency to market its next-generation video capsule PillCam SB 3, which can detect small bowel abnormalities related to Crohn’s disease and gastrointestinal bleeding.

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Israel-based medical devices developer Given Imaging has got clearance from the US regulatory agency to market its next-generation video capsule PillCam SB 3, which can detect small bowel abnormalities related to Crohn's disease and gastrointestinal bleeding.

Weighing less than 4g, the 11mm by 26mm video capsule features an imaging device and a light source that can transmit anywhere between two and six images in one second.

Due to software enhancements, the PillCam SB 3 offers a 40% more efficient video compilation than the earlier SB 2 version. The SB 3 will be available in the US towards the end of the year.

Given Imaging president and CEO Homi Shamir said that the 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," he said.

The latest version of the video capsule provides a 30% more efficient image resolution and comes with adaptive frame rate technology that offers detailed small bowel images and an improved video processing engine.

The Presbyterian Weill Cornell Medical Center's Jay Monahan Center for Gastrointestinal Health director Dr Felice Schnoll-Sussman said: "The improved image resolution and overall efficiency of the PillCam SB 3 system in capturing and analysing images of the small bowel has potential to have a meaningful impact on patient care."

In July, the company received approval for PillCam COLON in Japan.


Image: PillCam SB 3 video capsule. Photo: courtesy of Globenewswire/Given Imaging.