FDA OK's NinePoint software upgrade

Optical coherence tomography (OCT) technology developer NinePoint Medical received U.S. Food and Drug Administration (FDA) clearance to market its Intelligent Real-Time Image Segmentation (IRIS) software upgrade for its NvisionVLE imaging system.

IRIS, an artificial intelligence-based software for image feature segmentation, is used for imaging esophageal tissue.

The NvisionVLE imaging system allows physicians to perform a volumetric laser endomicroscopy (VLE) procedure that produces real-time, high-resolution cross-sectional images. The system enables gastroenterologists to evaluate the esophageal tissue surface and subsurface for potential disease that may not be visible with conventional medical imaging technologies such as endoscopy and ultrasound.

The new IRIS upgrade uses machine-learning algorithms to segment and visualize esophageal image features in real-time to assist clinicians as they identify and target regions of interest during an endoscopic procedure, the firm said.

The IRIS clearance marks the first addition to the NvisionVLE imaging system line since NinePoint Medical began collaborating with its worldwide distributor, Merit Medical Systems.

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