The US Food and Drug Administration (FDA) has cleared transformative medical device company NinePoint Medical to market NvisionVLE Imaging System for pancreas and bile duct applications, in addition to the previously existing esophageal use.

The Optical Coherence Tomography (OCT) imaging platform, NvisionVLE Imaging System, will help gastroenterologists to thoroughly evaluate tissue for regions of interest by providing real-time, high-resolution volumetric images of the tissue surface and subsurface.

NinePoint Medical said 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.

NinePoint Medical NvisionVLE Imaging System. Photo courtesy of NinePoint Medical, Inc.

Dr. Isaac Raijman – former Chief of Gastroenterology at Baylor St. Luke’s Medical Center said: “When a patient enters our care with an undiagnosed condition in the pancreatico-biliary system, the stakes can be very high.

“We have a number of tools today to help evaluate a patient’s condition within this anatomy. Unfortunately in many cases, our current toolset is unable to provide enough information to determine the best course of action.

“This is especially concerning for strictures or blockages of unknown origin. We are hopeful and excited that imaging beneath the surface with the NinePoint technology will supply the missing link and will enhance our clinical decision-making for these critically ill patients.”

In November 2018, NinePoint Medical received FDA-clearance for its artificial intelligence imaging technology Intelligent Real-time Image Segmentation (IRIS) for gastroenterology applications.

Eman Namati – President and CEO of NinePoint Medical said:  “Our group over the years has really pushed the limits of engineering innovation to help patients.

“This past year has been especially fruitful, with the clearance and market launch of a first-of-its-kind artificial intelligence technology, and now with the clearance of a pancreatico-biliary application for the Low-Profile Optical Probe.

“The ability to promote to this new anatomical space really strengthens the platform of the NvisionVLE Imaging System, and continues to build the opportunity for this technology to help patients.”

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