Submitted by kBLASTER Team on
by Brad Perriello for MassDevice
Medtronic (NYSE:MDT) said today that the FDA granted an expanded indication for the Pillcam Colon 2 device it acquired along with Covidien last year.
The new indication covers the detection of colon polyps in patients with bleeding in the lower gastrointestinal tract who’s health is at risk from colonoscopy or mild sedation, but could tolerate them if the Pillcam device detects an abnormality.
The vitamin-sized Pillcam is designed to provide images as it passes through the gastrointestinal tract after being swallowed. Covidien acquired its maker, Given Imaging, for $860 million in February 2014; Medtronic paid $50 billion for Covidien in January 2015.
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