U.S. FDA clears OCT imaging system for pancreatic and biliary applications

NinePoint Medical (Bedford, MA) has received U.S. FDA clearance to market its NvisionVLE Imaging System, an optical coherence tomography (OCT) imaging platform, for use in the pancreas and bile duct. These anatomical indications add to the previously existing esophageal applications for the system.

The OCT imaging system provides physicians real-time, high-resolution volumetric images of the tissue surface and subsurface, allowing gastroenterologists to thoroughly evaluate tissue for regions of interest that may not be visible with other medical imaging technologies. The newly cleared application is associated with the company'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. In the pancreas and bile duct, the ability to see beneath the tissue surface could help physicians answer a number of important clinical questions.

This clearance marks another significant step for the strategic collaboration between the company and its exclusive worldwide distributor, Merit Medical Systems (South Jordan, UT).

For more information, please visit ninepointmedical.com.