FDA Approves Disposable Colonoscope

System prevents patient-to-patient contamination

The FDA has granted 510(k) clearance for the Aer-O-Scope (GI View Ltd.), a disposable, self-propelled, joystick-controlled colonoscope system. The new system allows therapeutic access using standard tools, such as snares and forceps, to obtain biopsies or to perform polypectomies.

According to the manufacturer, the Aer-O-Scope is the first colonoscope to provide 360-degree visualization of the colon to detect polyps behind folds. In addition, there is no risk of contamination or disease transmission between patients from the device as it is to be used only once and then discarded.

Colorectal cancer is a major cause of cancer-related death in most western countries. This type of cancer can be prevented by the early detection and removal of polyps, which, if ignored, can develop into active cancer over a period of five to 10 years. More than 690,000 people worldwide die from colorectal cancer annually.

GI View is working on plans to introduce the Aer-O-Scope to the U.S. market. Post-marketing studies are also in preparation.

Source: GI View; September 20, 2016.