Yoqneam, Israel-based Given Imaging has received FDA marketing clearance for its new Given Diagnostic System, including the PillCam ESO video capsule for imaging the esophagus.
The new PillCam ESO video capsule is 11x26mm and includes two imaging sensors, one at each end of the capsule. Each imager captures two frames (images) per second, totaling four frames per second.
Given said it is submitting a special 510(k) application to the FDA for a higher frame rate version, which takes 14 frames per second. It recently launched the higher frame rate PillCam ESO in Europe and will eventually launch in the United States pending clearance from the FDA, the company said.
Following FDA clearance of the 14 frame per second PillCam, Given said it intends to upgrade its installed base with its RAPID 3 image processing software and an enhanced data recorder. The upgrade will make the existing installed base compatible with the new capsule and allow existing customers to obtain the full benefits of the new capsule, said Given.
The PillCam ESO will be commercialized through an alliance with InScope, a division of Ethicon Endo-Surgery Inc., a Johnson and Johnson company, which was signed between the companies in May 2004. According to the terms of the agreement, upon receipt of clearance for the higher frame rate PillCam ESO video capsule, Given will be entitled to a payment of $10 million from Ethicon Endo-Surgery, according to Given.