Israel-based medical devices developer Given Imaging has received the US Food and Drug Administration (FDA) clearance under the direct de novo classification for its video capsule to provide visualization of the colon that has a global market of three million procedures annually.
According to the company, the PillCam Colon may be used for detection of colon polyps in patients after an incomplete optical colonoscopy.
It is claimed to be the only non-invasive and radiation-free solution for the approximately 750,000 patients in the US who experience an incomplete colonoscopy each year.
Patients with incomplete colonoscopies often incur additional costs along with the inconvenience and risk of other procedures to complete the colorectal examination.
Given Imaging president and CEO Homi Shamir said the clearance of PillCam Colon by the FDA represents a pivotal moment in the evolution of Given Imaging as a GI medical device leader.
"While we believe that PillCam COLON will ultimately play an important role in both the global colorectal cancer diagnostic and screening market, this initial indication is an important first step," Shamir added.
"To this end, we are making good progress in advancing additional clinical studies that should support the expanded indications."
To date, PillCam COLON clinical data have been validated in 34 publications. PillCam Colon is commercially available in more than 80 markets including Japan, Europe, Latin America, Canada, Australia and parts of Asia and Africa.