FDA CLEARS NEOGUIDE'S COMPUTER-ASSISTED COLONOSCOPY SYSTEM

The FDA recently granted NeoGuide Systems 510(k) clearance to market its NeoGuide Endoscopy System.

The system is designed to enhance physician control of the colonoscope and to eliminate looping, the principle reason why conventional colonoscopy procedures are painful, time consuming, and difficult, the company said.

Colorectal cancer (CRC) is the second leading cause of cancer deaths in the United States, yet it is highly preventable. Colonoscopy is considered the standard method for CRC screening as it is the only screening method that allows the physician to inspect the entire colon and remove adenomatous polyps, the non-cancerous growths that have the potential to develop into colorectal cancer. Studies have shown that screening colonoscopy and the removal of polyps can prevent the vast majority of CRC cases.

In conventional colonoscopy, a flexible endoscope is inserted into the colon, which is essentially a flexible and highly tortuous tube. Advancing the colonoscope displaces the colon and stretches the surrounding tissue, a phenomenon known as looping. Unlike conventional scopes, the NeoGuide colonoscope is built out of multiple segments that can be actively controlled. As the physician inserts the NeoGuide scope, the system automatically creates a three-dimensional map of the colon and then directs these segments to follow the path taken by the tip.