Given Imaging Obtains FDA Clearance For PillCam Colon - Quick Facts

(RTTNews) - Given Imaging Ltd (GIVN) announced Monday that the U.S. Food and Drug Administration or FDA has cleared PillCam Colon as a new modality to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation and a complete evaluation of the colon was not technically possible.

The company stated that PillCam Colon received clearance under the direct de novo classification for devices with low to moderate risk that have no predicate on the market.

To date, PillCam Colon clinical data have been validated in 34 publications. PillCam Colon is commercially available in more than eighty markets including Japan, Europe, Latin America, Canada, Australia and parts of Asia and Africa, the company said.

The firm stated that the PillCam Colon video capsule is equipped with two miniature color video cameras (one on each end), a battery and an LED light source; it measures 12 mm X 33 mm. PillCam Colon is designed to be ingested by the patient and transmits 4 or 35 frames per second for approximately 10 hours to a recording device worn by the patient. Data are transferred from the device to a computer that uses RAPID software to compile the video data and enable the physician to review and report the results of the PillCam study.