The FDA has cleared Medtronic’s PillCam COLON 2 ingestible capsule for an expanded indication in patients who are at major risks for colonoscopy or moderate sedation. The device is about the size of a vitamin and is swallowed by the patient without the need of sedation, anesthesia or radiation.

This expanded indication is for the detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower gastrointestinal (Gl) origin. This 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 on capsule endoscopy.

press release
article in FierceMedical Devices