CENTER VALLEY, Pa., March 15, 2021 /PRNewswire/ — Olympus announced today 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. Patients and healthcare systems can benefit from implementation of NBI as a decision-making support tool.
The data submitted to the FDA in support of the 510(k) clearance included a meta-analysis of prospective real-time clinical studies of NBI use during colonoscopy.1 The data show experienced endoscopists employing a validated classification system, such as the NICE classification, have:
- Demonstrated 93% sensitivity (89-96%, 95% Confidence Interval, 59-98% range) in predicting adenomatous histology of diminutive polyps during colonoscopy when made with high confidence.