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Given Imaging’s PillCam Colon 2 Strategy Shift Will Delay Screening Claim

Firm initially will pursue diagnostic imaging claim for its PillCam Colon 2 video capsule, rather than a screening claim, as the fastest route to U.S. market. The strategy shift follows preliminary clinical trial data review.

Given Imaging Ltd. plans to pursue 510(k) clearance for its PillCam Colon 2 video capsule for diagnostic imaging of the colon, rather than for screening, as the fastest route to the U.S. market, the firm announced Aug. 8 during its second quarter earnings call.

While a broader screening indication has been a goal of the company, Given Imaging says that after reviewing most of the data from its 885-patient U.S. trial, it now plans...

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