FDA clears Medtronic's PillCam COLON 2 capsule for expanded indication: 4 things to know

Medtronic's PillCam COLON 2 capsule was cleared by the FDA for an expanded indication.

Here are four things to know:

1. The PillCam COLON 2 capsule is a non-invasive diagnostic test that allows direct visualization of the colon for the evaluation of polyps in patients.

2. The expanded indication relates to the detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower gastrointestinal origin.

3. The indication applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified.

4. The PillCam capsule is taken orally and does not require sedation, anesthesia or radiation.

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