Medical device firm NinePoint Medical has secured approval from the US Food and Drug Administration (FDA) for Intelligent Real-time Image Segmentation (IRIS) software upgrade for the NvisionVLE imaging system.


Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.

The NvisionVLE imaging system enables to carry out a volumetric laser endomicroscopy (VLE) procedure, which produces real-time and high-resolution cross-sectional images.

IRIS is an artificial intelligence-based platform for image feature segmentation, and is claimed to be the first of its kind secured approval for use in imaging of esophageal tissue.

The system allows gastroenterologists to completely assess the esophageal tissue surface and sub-surface for potential disease that may not be detected with conventional medical imaging technologies such as endoscopy and ultrasound.

NinePoint’s new IRIS upgrade uses advanced machine learning algorithms to segment and visualize esophageal image features in real-time, helping clinicians to identify and target regions of interest during an endoscopic procedure.

The approval of IRIS represents the first product addition to the NvisionVLE imaging system product portfolio, after NinePoint Medical collaborated with its worldwide distributor Merit Medical Systems.

Merit Medical chairman and CEO Fred Lampropoulos said: “We are thrilled to continue to see the innovation and development of high quality products from our collaborators at NinePoint.

“The NvisionVLE Imaging System has been a great strategic addition to the Merit Medical family of GI products, and we look forward to continuing to work together on future product releases.”

The NvisionVLE imaging system has been developed for use as an imaging tool in the assessment of human tissue microstructure, including esophageal tissue microstructure.

The software offers segmentation and display of common imaging features, including hyper-reflective surface, layering, and hypo-reflective structures.

NinePoint Medical president and CEO Eman Namati said: “The clearance of the IRIS product marks the successful culmination of a multi-year development effort within our organization, and with the Food and Drug Administration.

“This product is something we at NinePoint, and our customers, are very excited to bring to market. We pride ourselves in customer responsiveness and innovation, key inputs to this new product.”

NinePoint Medical provides optical coherence tomography (OCT) imaging platform for clinical use in gastroenterology, pulmonology, urology, gynecology, and ENT.