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FDA Lowers Risk Class for PillCam

Given Imaging petitioned for re-classification in 2012.

The U.S. Food and Drug Administration (FDA) has lowered the risk profile of the PillCam endoscopic camera, produced by the Covidien plc’s Israeli subsidiary Given Imaging. Given Imaging had sent a petition for the downgrade in Nov. 2012.

FDA has now classified the PillCam device as class II device. This lowers the reviewing criteria of the device from the premarket approval to the 510(k) premarket notification process. Previously, FDA has allowed Given Imaging to sell the device only as a back-up for patients who are incapable for a complete colonoscopy through traditional means.

Given Imaging’s PillCam is a capsule endoscope capable of capturing image of the digestive system when it is ingested. Per FDA, risks associated with the device include tissue reactions, failure to excrete the device, equipment malfunction and abdominal pain, nausea, vomiting, and choking.

Given Imaging was purchased by Dublin, Ireland-based Covidien in March this year.

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