Given Imaging (NSDQ:GIVN) said it won 510(k) clearance from the FDA for its PillCam Colon, a modified version of its PillCam device.
The PillCam Colon is designed to detect colon polyps in patients after an incomplete optical colonoscopy. The device is equipped with 2 miniature color video cameras and transmits 4 or 35 frames per second for 10 hours to a recording device worn by the patient. The device is cleared for use in several other markets, including Japan and Europe, according to a press release.
“The clearance of PillCam Colon by the FDA represents a pivotal moment in the evolution of Given Imaging as a GI medical device leader," president & CEO Homi Shamir said in prepared remarks. "We look forward to working closely with the U.S. gastroenterology community to bring this clinically-proven, diagnostic tool to patients who need to have a thorough colorectal exam following an incomplete colonoscopy. While we believe that PillCam Colon will ultimately play an important role in both the global colorectal cancer diagnostic and screening market, this initial indication is an important first step. To this end, we are making good progress in advancing additional clinical studies that should support the expanded indications.”
Late last year, Covidien (NYSE:COV) agreed to acquire Given Imaging or $860 million in a deal that’s expected to close in March.
