FDA clears NinePoint's OCT imaging catheter for use in bile ducts, pancreas

The FDA cleared a catheter-based imaging device that allows physicians to view the insides of the pancreas and bile duct in real time, using an optical coherence tomography system developed by NinePoint Medical.

After snaking its way into the pancreatic and bile duct network from the small intestine, the NvisionVLE system provides high-resolution, volumetric scans of the tissue surface and subsurface from within—using light in a method akin to how sound waves are used during an ultrasound, to form a cross-sectional image.

A previous Fierce 15 winner, NinePoint hopes the system will help gastroenterologists to more thoroughly evaluate the body’s bile ducts, including blockages of unknown origin, in the small and twisted channels that can present challenges for other imaging technologies. It can also be used to mark areas of tissue using a laser to guide tissue acquisition during a subsequent biopsy.

While it can provide doctors images of tissue microstructures, and up to 3 mm beneath the tissue’s surface, the NvisionVLE system has not been evaluated for its ability to diagnose any specific disease, according to NinePoint. Already commercially available, the new clearance expands upon the device’s previous uses in the esophagus.

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Last November, NinePoint received an FDA clearance for a software upgrade for its NvisionVLE system: an artificial intelligence-based platform for feature segmentation in the imaging of esophageal tissue.

The Intelligent Real-time Image Segmentation, or IRIS, platform aims to assist clinicians as they target different areas of the organ during an endoscopic procedure.