FDA Cleared Imaging

NinePoint Medical wins FDA clearance for NvisionVLE

NinePoint Medical yesterday announced that it received FDA clearance for its NvisionVLE Imaging System for use in the pancreases and bile duct.

The NvisionVLE Imaging System gives physicians real-time, high-resolution volumetric images of tissue surfaces and subsurfaces, according to the company. The new clearance adds on to the already existing indications for esophageal applications in NinePoint’s Optical Coherence Tomography imaging platform. Using the new clearance with the company’s Low-Profile Optical Probe, physicians can image small anatomies such as the pancreatic-biliary system.

“When a patient enters our care with an undiagnosed condition in the pancreatic-biliary system, the stakes can be very high,” said Isaac Raijman, former the chief of gastroenterology at Baylor St. Luke’s Medical Center, said in a press release. “We have a number of tools today to help evaluate a patient’s condition within this anatomy. Unfortunately, in many cases, our current toolset is unable to provide enough information to determine the best course of action. This is especially concerning for strictures or blockages of unknown origin. We are hopeful and excited that imaging beneath the surface with the NinePoint technology will supply the missing link and will enhance our clinical decision-making for these critically ill patients.”

Original Article: (https://www.massdevice.com/ninepoint-medical-wins-fda-clearance-for-nvisionvle/)

 

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