FDA issues expanded indication clearance for Medtronic Pillcam Colon 2 capsule

Medtronic has announced receipt of FDA clearance for expanded indication of use regarding its PillCam Colon 2 capsule endoscope.

The vitamin-sized camera—the only non-invasive diagnostic test capable of directly visualizing polyps in the colons of patients at major risks for colonoscopy or moderate sedation—now has expanded indication for the detection of colon polyps in patients with evidence of lower gastrointestinal bleeding.

"We are committed to the early detection and treatment of chronic GI diseases and cancers,” said Medtronic’s Vafa Jamali in a company press release. “We are pleased with the FDA's decision to clear this expanded indication for PillCam Colon capsule which will provide access to more patients who can benefit from this technology.”

The device, which does not require sedation, anesthesia or radiation, may also limit the risk of complications associated with colonoscopy such as perforation, bleeding or cardio-pulmonary complications.

Read the full Medtronic press release here.