NinePoint Medical, Inc. radiology AI products

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Radiology AI pricing and total cost of ownership

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FDA-cleared K182616

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System

NinePoint Medical, Inc.

Authorized purpose: The NvisionVLE Imaging System is an imaging tool for evaluating human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization and marking areas of tissue. The software provides segmentation and display of common imaging features including hyper-reflective surface, layering, and hypo-reflective structures. Safety and effectiveness for diagnostic analysis of normal versus a specific abnormality or disease have not been evaluated.

Modality: Optical Coherence Tomography
Anatomy: Human tissue microstructure, including esophageal tissue
Decision: 2018-11-02

Quantification and segmentation