Israel-based Given Imaging is slated to roll out its next-generation PillCam, a capsule-sized camera device used to monitor various GI diseases, after winning 510(k) clearance from the FDA.
The PillCam SB 3 has enhanced image resolution, frame rate and video processing power, according to the Yoqneam, Israel-based company. A new algorithm creates video 40% more efficiently than the PillCam SB 2, Given Imaging said.
"We believe PillCam SB 3 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," CEO Homi Shamir said in prepared remarks.
Given Imaging initially submitted its FDA application in December 2012. The PillCam is cleared for use in Japan, Europe, Latin America, Canada and parts of Asia.
The new PillCam is designed for patients with complicated and difficult-to-diagnose GI problems, such as abnormal bleeding or symptoms of Crohn’s disease and anemia.
"Our goal, as we set out to re-imagine and improve the PillCam platform, was not just to provide physicians with more information, but to provide them with better and more actionable information," Shamir said.