NaviCam ProScan

by Ankon Technologies Co., Ltd.  · Based in China → — Unlock the Future of Gastroenterology with ProScan – Your AI Assisted Reading Tool
Gastroenterology Radiology

Not disclosed
Regulatory Status Disclosed

Overview

NaviCam ProScan is an artificial intelligence (AI) assisted reading tool designed to revolutionize the diagnostic process for small bowel capsule endoscopy. It aids reviewers in significantly decreasing the time required to analyze pre-recorded capsule endoscopy videos, particularly for adult patients with suspected small bowel bleeding. The software utilizes advanced algorithms to identify and mark images and areas of interest, such as suspected lesions, and assists in pinpointing the digestive tract location (oral cavity and beyond, esophagus, stomach, small bowel).

ProScan is intended to enhance, not replace, clinical decision-making, empowering gastroenterologists to review studies more efficiently without sacrificing diagnostic accuracy. It integrates seamlessly with the NaviCam Small Bowel Capsule Endoscopy System and ESView software, streamlining diagnostic workflows and supporting consistent, high-sensitivity detection of various abnormalities like bleeding, ulcers, strictures, and inflammatory changes.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-assisted reading for small bowel capsule endoscopy
  • Decreases review time for capsule endoscopy images
  • Identifies suspected lesions and areas of interest
  • Assists in identifying digestive tract location
  • Enhances diagnostic yield and lesion detection rate
  • Integrates with NaviCam Small Bowel Capsule Endoscopy System
  • Compatible with ESView software for streamlined analysis
  • High sensitivity for lesion detection (e.g., 99.88% per-patient)
  • Supports consistent, high-sensitivity detection
  • Optimizes workflow and reduces interpretation burden

Use Cases

  • Reviewing small bowel capsule endoscopy images for suspected bleeding
  • Reducing physician reading time for capsule endoscopy studies
  • Identifying ulcers, strictures, and inflammatory changes in the small bowel
  • Determining the anatomical site of images within the digestive tract
  • Enhancing diagnostic workflow efficiency in gastroenterology practices
  • Improving confidence in patient management through faster insights

What Physicians Need to Know

Polyp/Lesion Detection During Small Bowel Capsule Endoscopy
NaviCam ProScan is an AI-assisted reading tool that recognizes and marks images containing suspected abnormal lesions in the small bowel, including polyp/bulging, inflammation/erosion/bleeding/ulcer, and diverticulum.
AI-Assisted Review of Recorded Endoscopy
The software processes pre-recorded capsule endoscopy images of the small bowel to aid in identifying suspected abnormal lesions and segmenting the digestive tract. It significantly reduces the time required for reviewing capsule endoscopy studies.
Lesion Detection Rate Improvement
ProScan has demonstrated an increased diagnostic yield and significantly higher lesion detection rate compared to conventional reading. Studies show per-patient sensitivity of 99.88% and per-lesion sensitivity of 99.90%, with 100% specificity.
GI Pathology Analysis Aid
The tool aids small bowel capsule endoscopy reviewers in recognizing and marking images with suspected abnormal lesions, supporting clinicians in analyzing areas of interest for potential pathology. It is not intended to replace histopathological sampling.
Capsule Endoscopy AI
NaviCam ProScan is the first FDA-cleared AI-assisted reading tool specifically designed for small bowel capsule endoscopy. It uses deep learning algorithms to differentiate normal mucosa from abnormal lesions and identify digestive tract locations.
Procedure Documentation Support
By automatically marking suspected lesions and segmenting digestive tract locations, ProScan streamlines the review process, which contributes to more efficient and accurate procedure documentation.
Quality Metrics Tracking
ProScan enhances diagnostic accuracy with exceptional sensitivity and specificity, and dramatically reduces reading time from over 30 minutes to less than 4 minutes, improving overall efficiency and diagnostic confidence.
Endoscopy System Compatibility
NaviCam ProScan is designed to be used exclusively with the NaviCam Small Bowel Capsule Endoscopy System and integrates seamlessly with its ESView software.
Physician Tip

NaviCam ProScan is an invaluable AI-assisted reading tool for small bowel capsule endoscopy, significantly reducing review time and enhancing lesion detection. Remember that it serves as an adjunct; the clinician remains responsible for reviewing the entire video, conducting their own assessment of the AI-assisted findings, and making the final clinical diagnosis. Utilize its precise digestive tract localization and high sensitivity to focus your review on areas of interest, especially for suspected small bowel bleeding, but always exercise your professional judgment and consider further evaluation if symptoms persist.

NaviCam ProScan is specifically engineered for seamless integration with the NaviCam Small Bowel Capsule Endoscopy System and its ESView software. It functions as an add-on to this existing platform, leveraging the captured capsule endoscopy images for AI-driven analysis.

Details

Category Gastroenterology AI, Radiology & Imaging AI
Pricing Not disclosed — N/A
DeploymentIntegrated software with proprietary hardware (NaviCam Small Bowel Capsule Endoscopy System)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

NaviCam ProScan received FDA De Novo classification (DEN230027) on December 12, 2023 (corrected December 16, 2024). It is classified as a Class II gastrointestinal capsule endoscopy analysis software device (21 CFR 876.1540). It is indicated as an AI-assisted reading tool to aid small bowel capsule endoscopy reviewers in decreasing review time and identifying suspected lesions and digestive tract locations. It is for prescription use only and not intended as a standalone diagnostic device.

Integrations
EHR Not specified
Specialties Gastroenterology, Radiology

What the Web Says

NaviCam ProScan is an AI-assisted reading tool designed to significantly reduce the time physicians spend reviewing small bowel capsule endoscopy images, particularly for suspected small bowel bleeding. It has received FDA de novo clearance and is the first AI-based tool of its kind to support small bowel capsule endoscopy reviewers. The system aims to enhance diagnostic workflows, improve efficiency, and provide clinicians with more informed decisions.

Overall: Positive

Strengths

  • Significantly reduces reading time for capsule endoscopy images (from an average of 58.10 minutes to 21.47 minutes in one study, and from 33.7 minutes to 3.8 minutes in another).
  • High sensitivity in detecting abnormalities and lesions (98% patient-level sensitivity, 95.05% image-level sensitivity, and 99.9% lesion detection sensitivity in some studies).
  • Enhances diagnostic accuracy and yield.
  • Assists in identifying digestive tract location.
  • FDA-cleared and clinically validated.
  • Improves workflow efficiency and diagnostic confidence.

Limitations

  • Patient-level specificity was 37%, suggesting clinicians need to carefully review findings to identify false positives.
  • AI standalone performance has not been established, and it is not intended to replace clinical decision-making.
  • Lack of lesion-level data introduces uncertainty regarding the ability of the device to detect individual lesions.
  • Some general 'ProScan' reviews (not specific to NaviCam ProScan) on Reddit and Capterra mention issues with older, underpowered tablets and slow systems, though these do not appear to be related to AnX Robotica's product.

Based on reviews from: accessdata.fda.gov, mpo-mag.com, nsmedicaldevices.com, prnewswire.com, anxrobotica.com, ncbi.nlm.nih.gov, endotherapeutics.com.au, aithority.com, clinicaltrials.gov, capterra.com, dallasinnovates.com, healio.com, reddit.com, g2.com

Last updated: 2026-07-17

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Press & Coverage

PR Newswire
AnX Robotica Announces FDA Clearance for ProScanu2122: A Groundbreaking AI Assisted Reading Tool for Small Bowel Video Capsule Endoscopy
AnX Robotica received FDA clearance for NaviCam ProScan, an AI-assisted reading tool for small bowel capsule endoscopy, making it the first such tool for adult patients with suspected gastrointestinal bleeding. The software aims to enhance diagnostic workflows and support clinicians in making informed decisions.
2024-01
Interventional News
AnX Robotica receives FDA clearance for small bowel capsule endoscopy technology
AnX Robotica's NaviCam ProScan, an AI-assisted reading tool, has received FDA clearance, aiming to revolutionize gastroenterology by aiding small bowel capsule endoscopy reviewers for adult patients with suspected gastrointestinal bleeding. The tool is designed to support, not replace, clinical decision-making.
2024-01
NS Medical Devices
FDA clears NaviCam ProScan for small bowel capsule endoscopy - NS Medical Devices
The FDA has approved AnX Robotica's NaviCam ProScan, an AI-assisted reading tool for small bowel video capsule endoscopy, which is the first AI-based tool to support reviewers in identifying suspected small bowel bleeding in adult patients. This clearance follows a rigorous De Novo Submission Process.
2024-01
AnX Robotica (Press Release)
AnX Robotica is Pleased to Announce FDA Clearance for Expanded Indications of NaviCam Small Bowel Video Capsule Endoscopy
AnX Robotica announced FDA clearance for expanded indications of its NaviCam Small Bowel Video Capsule Endoscopy for adults and children aged 2 and above, alongside the recent clearance of ProScan. This establishes NaviCam SB as a highly advanced technology in small bowel video capsule endoscopy.
2024-01
Healio
FDA grants de novo clearance to AnX Robotica's AI tool for small bowel capsule endoscopy
AnX Robotica received de novo FDA clearance for its NaviCam ProScan, an AI-assisted reading tool for small bowel capsule endoscopy procedures, intended to help reviewers identify suspected small bowel bleeding. The software is designed to support, rather than replace, clinician expertise.
2024-01
PMC (PubMed Central)
Recent technological advances in video capsule endoscopy: a comprehensive review
This review highlights NaviCam ProScan as an FDA-approved AI-assisted reading tool for small bowel video capsule endoscopy, noting its effectiveness in reducing reading time and improving lesion detection compared to conventional methods.
2025-09
PMC (PubMed Central)
Artificial Intelligence-Assisted Capsule Endoscopy for Obscure Small-Bowel Bleeding: A Systematic Review of Workflow Gains and the Unmeasured Impact on Patient-Centred Outcomes
This systematic review discusses the operational impact of AI-assisted capsule endoscopy, including NaviCam ProScan, on workflow and reading time for obscure small-bowel bleeding. It notes that AI assistance consistently and significantly reduces reading duration.
2025-11
PMC (PubMed Central)
The utility of artificial intelligence in visualization of pediatric gastrointestinal mucosa - PMC
This article mentions NaviCam ProScan as an FDA De Novo Classified AI-assisted reading tool for small bowel video capsule endoscopy, highlighting its role in reducing average reading time and improving lesion detection in multicenter trials.
2026-01

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Frequently Asked Questions

NaviCam ProScan is an FDA-cleared, AI-assisted reading tool for small bowel capsule endoscopy, designed to help physicians review images more efficiently. It uses deep learning algorithms to identify suspected abnormal lesions and pinpoint digestive tract locations, significantly reducing review time. However, it acts as a support system, and the clinician remains solely responsible for the final diagnosis and interpretation of findings.
NaviCam ProScan has received FDA clearance through the De Novo Submission Process, classifying it as a Class II prescription device. Physicians are responsible for operating the system in compliance with all applicable federal and state legal requirements, including interpreting data and providing medical advice. Postmarket surveillance data is also required to demonstrate its performance with physician input.
NaviCam ProScan aims to significantly reduce the time required for reviewing capsule endoscopy studies compared to traditional manual review, with studies demonstrating a dramatic decrease in reading time while enhancing diagnostic accuracy. While other capsule endoscopy systems exist, ProScan is noted as the first AI-based tool specifically for small bowel capsule endoscopy reviewers for adult patients.
NaviCam ProScan is an assistive tool and not a standalone diagnostic device, meaning it does not replace clinical decision-making. Its standalone AI performance in the absence of clinician input has not been established, and there is a potential for false negatives or positives if solely relied upon. Additionally, general capsule endoscopy limitations like capsule retention or unsuitability for patients with swallowing issues or strictures still apply.
Specific pricing details for NaviCam ProScan are not publicly available in the provided search results. Generally, medical device pricing can involve capital equipment costs for the system and per-use fees for capsules or software licenses. Interested physicians should contact AnX Robotica or their authorized distributors for detailed pricing and package options.
While specific training programs are not detailed in the search results, AnX Robotica provides the NaviCam system and software, implying support for its operation. Given its classification as a prescription device and the requirement for responsible operation by providers, comprehensive training on the system, its AI functionalities, and integration into clinical workflow would be expected.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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