The pancreatico-biliary clearance marks a very productive 12 months of product development activity for NinePoint Medical. In November of 2018, NinePoint announced the first FDA-cleared artificial intelligence imaging technology for gastroenterology applications, the Intelligent Real-time Image SegmentationTM (IRIS) product. “I’m so proud of the team here at NinePoint,” commented Eman Namati, Ph.D., President and CEO of NinePoint Medical. “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.”
About the NvisionVLE Imaging System
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The NvisionVLE Imaging System is designed to help gastroenterologists care for their patients. Current methods to identify abnormalities in the esophagus and bile duct can leave disease undetected. The NvisionVLE Imaging System, which leverages state-of-the-art Optical Coherence Tomography (OCT) imaging hardware, provides physicians with a high-resolution volumetric view of both the tissue surface and subsurface to guide tissue acquisition and decision making using more complete information. With the first FDA-cleared artificial intelligence imaging product in gastroenterology to aid image review, and the ability to create real-time superficial laser marks to guide tissue acquisition, there is no technology on the market like it.
The NvisionVLE Imaging System has been cleared by the FDA and is commercially available in the U.S. It is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization and may be used to mark areas of tissue. The software provides segmentation and display of common imaging features, including hyper-reflective surface, layering, and hypo-reflective structures. The Low-Profile Optical Probe, as part of the NvisionVLE Imaging System, is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal and pancreatico-biliary system tissue microstructures, by providing two-dimensional, cross-sectional, real-time depth visualization. The NvisionVLE Imaging System is intended to provide an image of tissue microstructure. The safety and effectiveness of this device for diagnostic analysis (i.e. differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.
