NvisionVLE Imaging

by NinePoint Medical, Inc.  · Based in United States → — See more deeply. See what's beneath the surface of the mucosal tissue.
Gastroenterology Oncology
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Regulatory Status Disclosed

Overview

The NvisionVLE® Imaging System is an advanced medical device that utilizes Volumetric Laser Endomicroscopy (VLE) and Optical Coherence Tomography (OCT) to provide high-resolution, cross-sectional, real-time imaging of human tissue microstructure. Developed by NinePoint Medical, Inc. and distributed by Merit Medical Systems, Inc., this system is primarily used in gastroenterology for evaluating the esophagus, pancreas, and bile duct.

It captures images up to 3mm deep with a 7-micron resolution, allowing for a thorough evaluation of 100% of the tissue in a 6cm scan. A key feature is its Intelligent Real-time Image Segmentation™ (IRIS) technology, which employs artificial intelligence algorithms to aid image review and identify areas of interest that may not be visible with conventional imaging modalities. The system also enables clinicians to create real-time superficial laser marks on tissue to guide targeted biopsies, potentially leading to improved diagnostic accuracy and more informed treatment decisions.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Volumetric Laser Endomicroscopy (VLE) technology
  • Advanced Optical Coherence Tomography (OCT) imaging
  • Real-time Targetingu2122 for precise evaluation
  • Intelligent Real-time Image Segmentationu2122 (IRIS) with AI algorithms for image review
  • High-resolution cross-sectional images (7 microns resolution, 3mm deep)
  • 100% tissue evaluation in a 6cm scan
  • Ability to create real-time superficial laser marks for biopsy guidance
  • User-friendly interface and hand controller for intuitive navigation
  • Single-use optical probes (balloon catheter or low-profile balloon-less options)
  • Compatible with endoscope channels 2.8mm or larger

Use Cases

  • Evaluation of human tissue microstructure in the esophagus, pancreas, and bile duct
  • Improved biopsy targeting for diagnosis by histopathology
  • Surveillance of Barrett's esophagus for early neoplasia/dysplasia detection
  • Guiding treatment selection for Barrett's esophagus (e.g., radiofrequency ablation)
  • Staging early squamous cell carcinoma
  • Guiding peroral endoscopic myotomy for achalasia

What Physicians Need to Know

Polyp Detection During Colonoscopy
While primarily indicated for esophageal and pancreatico-biliary imaging, the NvisionVLE system has been successfully utilized in a case to provide high-resolution images of a rectal polyp, aiding in defining its anatomy prior to surgery.
Real-Time Endoscopy AI
The NvisionVLE Imaging System delivers real-time, high-resolution cross-sectional images of tissue microstructure. Its Intelligent Real-time Image Segmentation (IRIS) software upgrade, an AI-based platform, uses machine learning algorithms to segment and visualize esophageal image features in real-time, assisting clinicians in identifying and targeting regions of interest during an endoscopic procedure.
Adenoma Detection Rate Improvement
The system is designed to improve dysplasia detection and surveillance, particularly in Barrett's esophagus, by enabling thorough evaluation of esophageal tissue microstructure and allowing clinicians to mark suspicious areas not visible with conventional imaging modalities. This capability can lead to improved biopsy targeting for diagnosis.
GI Pathology Analysis
NvisionVLE provides high-resolution, subsurface imaging (up to 3mm deep at 7-micron resolution), offering a more comprehensive evaluation of tissue microstructure. This detailed visualization, coupled with the AI-based IRIS platform for image feature segmentation, can enhance biopsy targeting for histopathological diagnosis.
Procedure Documentation
The system facilitates procedure documentation by allowing clinicians to create superficial laser marks on areas of suspicion during the Volumetric Laser Endomicroscopy (VLE) scan, providing visual guidance for subsequent tissue acquisition and treatment planning.
Endoscopy System Compatibility
The NvisionVLE Imaging System's optical probe catheter is compatible with standard endoscope channels that are 2.8mm or larger.
Physician Tip

Leverage the NvisionVLE's real-time, high-resolution subsurface imaging to identify and precisely target subtle tissue abnormalities, especially in Barrett's esophagus and pancreatico-biliary applications, that may be missed by conventional endoscopy. Utilize the IRIS AI for enhanced visualization and segmentation of suspicious features to guide more accurate biopsies and improve diagnostic yield. Integrate the laser marking capability to ensure precise correlation between imaging findings and biopsy locations, optimizing patient management and treatment decisions.

The NvisionVLE Imaging System is designed to be used in conjunction with existing endoscopy systems, with its optical probe catheter compatible with endoscope channels 2.8mm or larger. The IRIS AI is an integrated software upgrade that enhances the system's real-time imaging capabilities.

Details

Category Gastroenterology AI, Oncology AI, Radiology & Imaging AI
Pricing Contact for pricing — Pricing information is not publicly available; contact sales for a quote.
DeploymentOn-premise (console-based medical device)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The NvisionVLE Imaging System has received multiple 510(k) clearances from the U.S. FDA, including #K143678, #K153479, and #K182616. It 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 and may be used to mark areas of tissue. The software provides segmentation and display of common imaging features.
Integrations
EHR Not specified
Specialties Gastroenterology, Oncology

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Press & Coverage

Imaging Technology News
FDA Clears NvisionVLE Imaging System for Pancreatic and Biliary Applications
NinePoint Medical Inc. received U.S. FDA clearance for its NvisionVLE Imaging System for use in the pancreas and bile duct, expanding its existing esophageal applications. The system provides real-time, high-resolution volumetric images of tissue surface and subsurface, aiding gastroenterologists in evaluating areas not visible with other imaging technologies.
2019-08
NS Medical Devices
FDA approves NinePoint's NvisionVLE imaging system for pancreatic - NS Medical Devices
NinePoint Medical secured FDA approval for its NvisionVLE imaging system for pancreatic and biliary applications, which is claimed to be the first FDA-cleared artificial intelligence imaging product in gastroenterology. The system assists in image review and real-time superficial laser marks to guide tissue acquisition.
2019-08
NAI 500
NinePoint Medical Announces FDA Clearance of an Artificial Intelligence Software Upgrade for the NvisionVLEu00ae Imaging System | NAI 500
NinePoint Medical received FDA clearance for its Intelligent Real-time Image Segmentation (IRIS) software upgrade for the NvisionVLE Imaging System. IRIS is an AI-based platform that uses machine learning algorithms to segment and visualize esophageal image features in real-time, assisting clinicians in identifying and targeting regions of interest.
2018-11
Arboretum Ventures
Boston Scientific Announces Acquisition Of nVision Medical Corporation
Boston Scientific acquired nVision Medical Corporation, a company focused on women's health, which developed the first FDA-cleared device to collect cells from fallopian tubes for potential earlier diagnosis of ovarian cancer.
2018-04
BioSpace
New Clinical Data Using the NvisionVLE Imaging System to Be Presented at the World Congress of Gastroenterology At ACG 2017 and UEGW 2017 - BioSpace
NinePoint Medical announced that new clinical data related to its NvisionVLE Imaging System with Real-time Targeting will be presented at two major gastroenterology conferences. The system provides high-resolution, real-time scans of the esophagus using Optical Coherence Tomography (OCT) to view structures not evident with conventional imaging.
2017-10
Journal Articles (Donald and Barbara Zucker School of Medicine Academic Works)
Volumetric laser endomicroscopy and its application to Barrett's esophagus: results from a 1,000 patient registry.
A multi-center registry study utilizing the NvisionVLE Imaging System found that VLE identified focal areas of concern in 77% of Barrett's Esophagus (BE) procedures and guided tissue acquisition in over 70% of procedures. VLE improved neoplasia diagnostic yield by 55% beyond standard care.
2019-11
Translational Gastroenterology and Hepatology
A primer to image enhanced endoscopy - Translational Gastroenterology and Hepatology
Volumetric laser endomicroscopy (VLE), using the NvisionVLE Imaging System, is a new endoscopic imaging technology that provides widefield scanning and detailed imaging of surface and subsurface epithelium in the esophagus. This technology, utilizing advanced optical coherence tomography, is particularly useful in Barrett's surveillance endoscopy.
2022-08
Aesthetic Surgery Journal (Oxford Academic)
Growth in FDA-Approved Artificial Intelligence Devices in Plastic Surgery: A Key Look Into the Future - Oxford Academic
The NvisionVLE Imaging System (NinePoint Medical Inc.) was noted as an FDA-approved AI-driven software for enhanced imaging in surgical procedures, aiding in precise identification and marking of tissue areas. However, NinePoint Medical Inc. filed for Chapter 11 bankruptcy in October 2020.
2024-10

Videos

Product demos, reviews, and walkthroughs for NvisionVLE Imaging.

View all on YouTube

Frequently Asked Questions

The NvisionVLE Imaging system incorporates Intelligent Real-time Image Segmentation (IRIS) software, an AI-based platform that assists in image review and the creation of real-time superficial laser marks. This AI helps clinicians identify and target regions of interest during an endoscopic procedure, potentially leading to improved biopsy targeting.
NvisionVLE Imaging is FDA-cleared for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal, pancreatic, and biliary applications. It integrates into standard endoscopy procedures by providing real-time, high-resolution volumetric images of the tissue surface and subsurface, enabling a more thorough evaluation than conventional imaging.
The NvisionVLE Imaging system, including its Intelligent Real-time Image Segmentation (IRIS) AI software, has received multiple 510(k) clearances from the U.S. Food and Drug Administration (FDA). This makes it the first FDA-cleared artificial intelligence imaging product in gastroenterology.
While specific details on data privacy protocols are not extensively detailed in public search results, NinePoint Medical states they have a large dataset of anonymized, clinical data from OCT scans enhanced by their IRIS AI solution available in the public cloud. As an FDA-cleared medical device, it would be subject to stringent healthcare data privacy regulations like HIPAA in the U.S.
Primary alternatives for subsurface tissue evaluation include endoscopic ultrasound (EUS) and confocal laser endomicroscopy (CLE). NvisionVLE, utilizing advanced Optical Coherence Tomography (OCT), offers higher resolution (7 microns) and a wider field of view and depth (3mm) compared to EUS, and a significantly larger field of view than CLE, enabling more comprehensive real-time subsurface imaging.
A key limitation is that the safety and effectiveness of the NvisionVLE Imaging system for diagnostic analysis (i.e., differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated. While the AI assists in image review and targeting, it is not cleared for definitive diagnostic analysis.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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