Having received FDA appropriate clearances, NinePoint Medical is now making available in the U.S. its NvisionVLE esophageal tissue imaging system. The device provides a cross-sectional view of the tissue microstructure thanks to something called OFDI (optical frequency-domain imaging), a type of Fourier-domain optical coherence tomography (OCT).
The system is primarily intended to be used in imaging upper GI for diagnosis of Barrett’s esophagus and esophageal dysplasia.
From the announcement:
In December 2011, the NvisionVLE Imaging System received 510(k) clearance from the U.S. Food and Drug Administration for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross sectional, real-time depth visualization. Last month, NinePoint received 510(k) clearance to expand the System’s indication to include imaging of esophageal tissue microstructure.
Originally developed at the Wellman Center for Photomedicine at Massachusetts General Hospital (MGH), NinePoint licensed the imaging technology from MGH in 2010 as part of the largest intellectual property agreement for medical device technology in the hospital’s history. The NvisionVLE Imaging System enables physicians and pathologists to endoscopically view real-time, high-resolution, cross sectional images of organs and tissues up to 3mm deep at better than 10 micron resolution.
Product page: NvisionVLE Imaging System…