March 15, 2021 – Olympus (Center Valley, PA) received FDA 510(k) clearance of Narrow Band Imaging (NBI) to assess the neoplastic potential of colorectal polyps.
By applying the NBI International Colorectal Endoscopic (NICE) classification during a screening colonoscopy, physicians can make high-confidence predictions of histology for polyps 5mm or smaller, known as diminutive polyps.
Typically, polyps are detected and removed during colonoscopy and sent out for pathological diagnosis. Given the abundance of diminutive colorectal polyps, the American Society for Gastrointestinal Endoscopy (ASGE) recognized the importance of making real-time predictions of polyp histology. ASGE created a Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) initiative to assess technologies for the ability to aid physicians in the characterization of polyps. Of the technologies evaluated by ASGE’s PIVI initiative, NBI was the only one shown to meet the performance criteria for incorporation in clinical practice, the company said.
NBI is an optical imaging technology that enhances the visibility and contrast of vessels and surface patterns on the mucosa. Unlike white light, which uses all colors in the spectrum, NBI filters out all but blue and green light which are absorbed by hemoglobin and penetrate only the surface of human tissue. NBI also has clinical applications in urology, pulmonology and rhinolaryngology (ENT).
In addition to the current indications for NBI, Olympus has received FDA clearance for the screening and surveillance of Barrett’s esophagus and is currently exploring other claims for NBI both in gynecology and general surgery.