NinePoint’s NvisionVLE Receives Approval from FDA

by Savitha C Muppala on Apr 30 2013 8:12 AM

 NinePoint’s NvisionVLE Receives Approval from FDA
NinePoint Medical made an announcement following the approval by the FDA for its NvisionVLE Imaging System to be marketed for imaging of esophageal tissue microstructure.
NvisionVLE helps in enabling a 3D image from one scan of the observed organ in record time, which is less than 60 seconds.

Explaining the system, Charles Carignan, M.D., president and chief executive officer of NinePoint Medical, said, “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.”

“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,” he added.