Optical coherence tomography (OCT) imaging system developer NinePoint Medical (Cambridge, MA) has received an additional FDA clearance for its NvisionVLE Imaging System, adding a utility for imaging esophageal tissue microstructure. In January 2012, the company announced FDA clearance to market the system for use as an imaging tool in evaluating human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization.
Related: NinePoint Medical OCT imaging system garners FDA clearance
âThe NvisionVLE Imaging System is the first and only volumetric optical coherence tomography device cleared by the FDA for endoscopic imaging, and now imaging of esophageal tissue microstructure,â says Charles Carignan, MD, president and chief executive officer of NinePoint Medical. âExpanded FDA 510(k) clearance for imaging of the esophagus represents an important milestone as we progress toward commercializing the NvisionVLE Imaging System this year. We believe that the NvisionVLE Imaging System will allow physicians to see more esophageal tissue for biopsy and treatment procedures, providing them with valuable imaging information.â
Editors' note: Please stay tuned for the May/June issue of BioOptics World, which will include a cover feature on NinePoint Medical's Nvision VLE OCT imaging system and its utility for esophageal imaging.
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