Video-capsule manufacturer Given Imaging has received marketing clearance from the U.S. Food and Drug Administration for its Given Diagnostic System, including the PillCam ESO video capsule for imaging the esophagus, according to the Yoqneam, Israel-based firm.
The new PillCam ESO video capsule is the same size as the company's small bowel video capsule, PillCam SB, which is 11 mm x 26 mm. The PillCam ESO capsule includes two imaging sensors, one at each end of the capsule. Each imager captures two frames per second for a total capture rate of four frames per second, Given said.
The company also has submitted a special 510(k) application to the FDA for a higher frame rate version of the PillCam ESO. Given Imaging recently launched the higher frame rate device in Europe and will launch in the U.S. pending clearance from the FDA, the company said.
Following FDA clearance of the 14-frame per second camera, Given intends to upgrade its installed base with 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 those customers to obtain the full benefits of the new capsule, according to Given.
By AuntMinnie.com staff writers
October 26, 2004
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