NeoGuide’s Endoscopy System Gets FDA 510(k) Clearance
NeoGuide Systems, Inc. announces its computer-assisted colonoscope is now approved by the FDA. While conventional colonoscopy uses a flexible endoscope that tends to push on the colon (a phenomenom called looping) resulting in longer and more painful procedures, the NeoGuide colonoscope is built out of multiple segments that can be actively controlled, thus moving up the colon more easily. Currently, looping prevention is one of the important parts of colonoscopy training.
Colonoscopy is useful to screen colorectal neoplasia and while colorectal cancer (CRC) is highly preventable, it is the second leading cause of cancer deaths in the United States. The American Cancer Society estimates the number of diagnosed CRCs and deaths caused by it at about 145,000 and 56,000 per year respectively. Slow but steady progress is finally happening on that front. NeoGuide completed its initial clinical study of the system in September 2005 at Klinikum der Stadt Ludwigshafen in Ludwigshafen, Germany. Results of the study will be presented at the 2006 Digestive Disease Week (DDW) meeting in May.
February 9, 2006 Related topics: Product Approval & Certification, Endoscopy