in vivo imaging company NinePoint Medical, Inc. has received an additional FDA 510(k) clearance for its NvisionVLE™ Imaging System, expanding the system’s indication to include imaging of esophageal tissue microstructure.
NinePoint Medical, Inc. describes itself as a transformational medical device company developing innovative, real-time, in vivo imaging devices focused on dramatically improving patient care. It claims its proprietary NvisionVLE™ Imaging System enables physicians and pathologists, for the first time, to view real-time, high-resolution, volumetric images of organs and tissues up to 3mm deep at better than 10 micron resolution.
NinePoint is preparing for a commercial launch of the NvisionVLE Imaging System in the U.S. in May 2013. The NvisionVLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, now including esophageal tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization.
In January 2012, the NinePoint Medical announced 510(k) clearance to market its NvisionVLE Imaging System for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross sectional, real-time depth visualization.
“The 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,” said Charles Carignan, M.D., president and chief executive officer of NinePoint Medical. “Expanded 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.”
Source: NinePoint Medical, Inc.