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# FDA Clears Expanded Indication for Medtronic PillCam
- URL: https://www.fdaweb.com/fda-clears-expanded-indication-for-medtronic-pillcam/
- Published: 2016-03-31T12:00:00.000Z
- Updated: 2026-09-14T20:51:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135245

> FDA has cleared a Medtronic 510(k) for its PillCam COLON 2 capsule for an expanded indication — detecting colon polyps in patients with evidence of gastrointestinal bleeding of lower gastrointestinal origin. The device was originally cleared to visualize the colon for evaluating polyps in patients who are at major risks for colonoscopy or moderate sedation. The capsule endoscope is to be taken orally, and does not require sedation, anesthesia or radiation. The capsule technology may also “limit the risk of complications that could occur from a standard colonoscopy, such as colon perforation, bleeding or cardio-pulmonary complications,” the company says.