FDAnews Device Daily Bulletin

Medtronic Gains Expanded Indication for Pillcam Colon 2 Capsule

April 1, 2016

The FDA has granted Medtronic an expanded indication to the company’s Colon 2 capsule for pinpointing colon polyps in patients suffering from lower gastrointestinal bleeding.

The diagnostic test is intended to treat patients who could tolerate colonoscopy or moderate sedation.

The PillCam is taken orally and views the colon and does not require sedation, anesthesia or radiation.

The test was previously cleared by the FDA for detecting colon polyps in patients subsequent to an incomplete colonoscopy with reasonable preparation that could not achieve a full evaluation. — Anisa Jibrell