NinePoint Medical 

12 Oak Park Drive

Bedford, MA 01730

Phone: (617) 250-7190
Fax: (617) 250-7199
info@ninepointmedical.com

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© 2019 NinePoint Medical, Inc. NvisionVLE® and NinePoint Medical are registered trademarks of NinePoint Medical, Inc.  NinePoint Medical was founded in partnership with Third Rock Ventures and Prospect Ventures. (900289 Rev. A)

Indication for Use (USA Only)

The NvisionVLE® Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization and may be used to mark areas of tissue. The software provides segmentation and display of common imaging features, including hyper-reflective surface, layering, and hypo-reflective structures.

The Low-Profile Optical Probe, as part of the NvisionVLE Imaging System, is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal and pancreatico-biliary system tissue microstructures, by providing two-dimensional, cross-sectional, real-time depth visualization.

The NvisionVLE Imaging System is intended to provide an image of tissue microstructure. The safety and effectiveness of this device for diagnostic analysis (i.e. differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.