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Medical Devices / Submissions and Approvals

NinePoint’s Imaging System Cleared by FDA

Aug. 9, 2019
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NinePoint Medical’s NvisionVLE Imaging System has received 510(k) clearance for use in the bile duct and pancreases.

The device’s new clearance allows it to be used to generate high-resolution, real-time volumetric images of tissues and subsurfaces in the pancreatic-biliary systems.

The imaging system is designed to be used with the company’s Low-Profile Optic Probe, which enables physicians to image small anatomies such as the pancreas and bile duct.

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