Feb 092014
 

The PillCam Colon has been approved for us in the US by the FDA

Colonoscopies can be an uncomfortable procedure for patients who may already be worried about what results will be found.

When the results are inconclusive, a patient’s options can be limited, causing further distress. The US Food and Drug Administration (FDA) has now approved a device for use after an incomplete procedure that is minimally invasive and can achieve similar imaging results to a colonoscopy. PillCam Colon is a pill-sized camera that is swallowed and passes through a patient’s gastrointestinal tract.

Given Imaging‘s PillCam Colon was created specifically with the purpose of checking for colon cancer and is already commercially available in more than 80 countries. The study on which the FDA based its decision focused on identifying hyperplastic polyps and adenomas at least 6 mm in size. It found a 69 percent positive agreement between PillCam Colon results and a colonoscopy, and an 81 percent negative agreement.

A colonoscopy is the examination of a patient’s bowel using a long, thin camera known as an endoscope that is inserted via the rectum. Around 750,000 incomplete colonoscopies occur each year in the US, and are more common in women due to higher incidences of previous pelvic surgery and anatomical challenges for navigation. An incomplete colonoscopy often requires that a patient undergoes an additional procedure, such as an X-ray or CT scan, in order to complete the colorectal examination, incurring extra costs and risks in the process.

The device itself is a pill-sized video camera measuring 12 x 33 mm (0.47 x 1.3 in) that captures color video from both of its ends at 4 or 35 frames per second. An LED provides the necessary illumination for image capture and, once swallowed by the patient, it wirelessly relays footage to a recording device worn by the patient for approximately 10 hours.

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