NvisionVLE cleared for pancreatic and biliary imagingOctober 8, 2019
The US FDA has granted approval to market the NvisionVLE Imaging System for use in the pancreas and bile duct, NinePoint Medical, Inc said.
These anatomical indications add to the previously existing oesophageal applications for NinePoint’s Optical Coherence Tomography (OCT) imaging platform.
The NvisionVLE Imaging System provides physicians real-time, high-resolution volumetric images of the tissue surface and subsurface. This allows gastroenterologists to thoroughly evaluate tissue for regions of interest that may not be visible with other medical imaging technologies.
The new application is associated with NinePoint’s Low-Profile Optical Probe, a 7 French diameter imaging probe designed to handle small and tortuous anatomies, such as those found in the pancreatico-biliary system. It helps the physicians with the ability to see beneath the tissue surface in the pancreas and bile duct.