FDA Cleared Imaging

NvisionVLE System FDA Cleared to Analyze Pancreas and Bile Duct

NinePoint Medical, based out of Bedford, Massachusetts, won FDA clearance for its NvisionVLE Imaging System to be used in assessing the pancreas and bile duct.

The system can image tissue around a catheter tip up to 3 mm below the surface.

It does so thanks to a rotating light beam emanating from the catheter as it is moved through the pancreas or bile duct.

The system creates 2D slices of the surrounding tissue, which it can then reconstruct into a 3D representation and provide a variety of 2D visualizations to allow clinicians to better understand the relevant anatomy.

At 7 micron resolution, the system can provide images up to 25 times crisper than endoscopic ultrasound. Constrictions are pretty easy to detect using this technology.

It is even possible to create superficial laser marks to help guide tissue acquisition.

During procedures, a device similar to a remote control is used to navigate the catheter and image the target areas.

Original Article: (https://www.medgadget.com/2019/08/nvisionvle-system-fda-cleared-to-analyze-pancreas-and-bile-duct.html)

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