NinePoint Medical has received US Food and Drug Administration (FDA) clearance to market the NvisionVLE Imaging System for use in the pancreas and bile duct.
Physicians can use the NvisionVLE Imaging System to obtain real-time, high-resolution volumetric images of the tissue surface and subsurface.
Gastroenterologists will be able to thoroughly evaluate tissue for regions that may not be visible via medical imaging technologies.
NinePoint noted that the newly cleared application is associated with the company’s 7 French diameter imaging probe Low-Profile Optical, which has been designed to handle small and tortuous anatomies.
The probe is designed to be used as an imaging tool in the evaluation of human tissue microstructure.
Last November, the company announced the first artificial intelligence (AI) imaging technology cleared by the FDA for gastroenterology applications, the Intelligent Real-time Image Segmentation (IRIS) solution.
NinePoint Medical president and CEO Eman Namati said: “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 pancreaticobiliary application for the Low-Profile Optical Probe.
“The ability to promote 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.”
The latest approval by the FDA represents another important step for the strategic collaboration between NinePoint Medical and its exclusive worldwide distributor, Merit Medical Systems.
Commercially available in the US, the NvisionVLE Imaging System leverages Optical Coherence Tomography (OCT) imaging hardware and is indicated for use as an imaging tool to assess human tissue microstructure.
NinePoint has not evaluated the safety and effectiveness of the NvisionVLE Imaging System for diagnostic analysis in any tissue microstructure or specific disease.