The pill-shaped camera, developed by Israeli company Given Imaging, is a non-invasive and radiation-free alternative for patients who are unable to have a complete colonoscopy.
The PillCam COLON navigates through a patient's intestines over an eight-hour period, taking high-speed images that are sent to a device worn by a patient that are later examined by a doctor.
The company conducted an 884-patient, 16-site clinical trial studying the accuracy and safety of PillCam COLON compared to optical colonoscopy in detecting adenomas six millimetres or larger.
Results from this clinical trial demonstrated that the sensitivity for PillCam COLON was 88 per cent and specificity was 82 per cent in detecting adenomas, the company said.
The Food and Drug Administration (FDA) based its clearance decision on an analysis of this clinical trial data that used a more restrictive methodology for matching polyps.
"PillCam COLON will improve patient care by offering a new and effective colon imaging option for patients who have experienced an incomplete colonoscopy," said Douglas Rex, Distinguished Professor of Medicine and Chancellor's Professor, Indiana University School of Medicine.
"Among the limited alternatives available after incomplete colonoscopy, PillCam COLON gives us a minimally invasive, radiation-free option that provides endoscopic images of the same basic type that have made colonoscopy so useful," said Rex.
Incomplete colonoscopies occur in approximately 750,000 patients in the US per year, according to the company.
Patients with incomplete colonoscopies often incur additional costs along with the inconvenience and risk of other procedures to complete the colorectal examination.
The incidence of incomplete colonoscopies is higher in women due to the increase in past pelvic surgeries and the differing anatomy of women that includes particularly acute rectosigmoid angles in thin women.