FDA Grants Pre-Market Notice to NinePoint OCT Device
The Food and Drug Administration granted 510(k) pre-market notification for a new diagnostic imaging tool that reports to look deep into diseased tissue. NinePoint Medical Inc. describes the Nvision VLE Imaging System as the “only technology that can generate a volumetric image of the target organ in real-time that can be viewed simultaneously in cross section and longitudinally,” according to a press release. The new technology uses optical coherence tomography to look deeper than endoscopy alone, beneath the mucosal surface using a “circumferential scanning technique and an automatic pullback to generate cross sectional and longitudinal images simultaneously in real-time,” states the release. NinePoint expects the Nvision to change the standard of care by spotting disease earlier and possibly avoiding unnecessary biopsies. Clinical trials begin in 2012 with commercial use planned in 2013.