The U.S. Food and Drug Administration (FDA) has cleared device manufacturer Medtronic's PillCam Colon 2 capsule for detecting colon polyps in patients with evidence of gastrointestinal bleeding.
PillCam is a vitamin-sized capsule endoscope that is taken orally and does not require sedation, anesthesia, or radiation. The new application cleared by the FDA applies to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation if a clinically significant colon abnormality was found on capsule endoscopy, Medtronic said.