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Medical Devices / Regulatory Affairs / Commercial Operations

Given Imaging’s PillCam COLON Approved Via De Novo Pathway

Feb. 4, 2014

Given Imaging plans to launch its PillCam COLON in the U.S. by the end of the first quarter or early next quarter, following approval for use in patients who received an incomplete colonoscopy for reasons other than inadequate preparation.

The system — including capsule, patient’s data recorder and computer software that compiles video footage — was cleared via the de novo approval pathway for low-risk devices that have no predecessor on the market, Given CEO Homi Shamir said Monday.

In a clinical study of 884 patients, PillCam COLON identified 68.8 percent of patients with at least one polyp measuring 6 mm or larger and 64.9 percent with at least one polyp 10 mm or larger, the Israeli devicemaker said.

The device has a color video camera at either end and transmits between four and 35 frames per second over a 10-hour period to a recording device worn by the patient. A computer then compiles the video footage.

PillCam COLON is already available in Japan. — Lena Freund

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