Products

EndoScreener
Chengdu Wision Medical Device Co.
Gastroenterology AI
EndoScreener is an FDA-cleared AI-assisted polyp detection software that provides real-time visual and audible alerts for potential colorectal polyps during colonoscopy procedures.

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About Chengdu Wision Medical Device

Chengdu Wision Medical Device, operating as Wision A.I., is a healthcare AI company specializing in advanced diagnostic algorithms and systems for clinical imaging, primarily focusing on gastrointestinal endoscopy and histopathology. Their flagship product, EndoScreener, is an AI-assisted polyp detection software designed to enhance colonoscopy procedures. It provides real-time visual notifications and sound alarms to aid endoscopists in identifying polyps during colonoscopy, integrating seamlessly with most mainstream endoscope systems.

For physicians, EndoScreener offers significant clinical benefits by improving adenoma detection rates and reducing the miss rate of precancerous lesions. Clinical trials involving over 5,000 patients have demonstrated its efficacy, showing a reduction of 41% in precancerous lesion miss rate and a 33% improvement in adenoma per colonoscopy (APC). The software is a Class II medical device, having received CE Mark approval under the new Medical Devices Regulation (MDR 2017/745), FDA 510(k) clearance, and NMPA Class III approval. This technology aims to contribute to the prevention of colorectal cancer by facilitating earlier and more accurate detection, thereby optimizing patient outcomes and potentially reducing healthcare expenditures.

Beyond colonoscopy, Wision A.I. is also developing tools for histopathological diagnosis, such as an AI-based tool for whole slide localization of cancerous regions in tissue sample slides. The company emphasizes integrating medical knowledge with cutting-edge convolutional neural networks and general-purpose computing to achieve stable and robust detection efficacy in diagnostic imaging, with a focus on solving problems with smaller datasets and respecting the mathematical essence of deep learning.

Focus Areas

AI-assisted diagnostics optical medical imaging gastrointestinal endoscopy histopathology colorectal cancer screening polyp detection computer-aided diagnosis (CAD)

Business Intelligence

Key InvestorsMedTech Innovator, Northern Light Venture Capital
PartnershipsMicro-Tech Endoscopy USA (U.S. GI endoscopy distributor for EndoScreener)
TechnologyCloud-native (implied by 'scalable models' and 'general-purpose computing'), deep learning AI, convolutional neural networks (CNNs), Computer Aided Polyp Detection (CADe) systems
FDA Clearances1 cleared products (estimated)

What Physicians Need to Know

AI-assisted Diagnostics
Chengdu Wision Medical Device specializes in AI-assisted diagnostics, particularly with their flagship product, EndoScreener, for real-time polyp detection during colonoscopies. The EndoScreener has received FDA 510(k) clearance and CE-MDR Class II certification. They also have an upcoming histopathology AI software for localizing high-grade dysplasia (HGD) in whole slide imaging for colorectal specimens, and have launched PathoCruz 3D for automated histological 3D reconstruction to reveal tumor spatial characteristics.
Optical Medical Imaging
The company develops computer-aided diagnosis (CAD) algorithms and systems for clinical imaging, specifically in optical medical imaging modalities like endoscopy and histopathology. Their technology enhances the detection efficacy in diagnostic imaging by integrating medical knowledge into scalable models.
Gastrointestinal Endoscopy
Wision A.I.'s EndoScreener is an AI-assisted polyp detection software designed for gastrointestinal endoscopy procedures. It provides real-time visual notifications (blue boxes) and sound alarms for potential polyps during colonoscopy, assisting endoscopists.
Histopathology
Beyond endoscopy, Wision A.I. is advancing in histopathology with AI software to assist in localizing high-grade dysplasia (HGD) in whole slide imaging (WSI) for colorectal specimens. Their PathoCruz 3D tool offers automated histological 3D reconstruction, providing spatial accuracy for enhanced tumor diagnostics, including size, shape, invasion depth, and volume.
Colorectal Cancer Screening & Polyp Detection
A core specialization is colorectal cancer screening through improved polyp detection. EndoScreener has demonstrated significant efficacy in improving adenoma detection on over 5,000 patients in six rigorous randomized controlled trials, reducing precancerous lesion miss rates by 41% and improving adenoma per colonoscopy (APC) by 33%.
Computer-Aided Diagnosis (CAD)
The company builds Computer-Aided Diagnosis (CAD) algorithms and systems to improve diagnostic accuracy and effectiveness in clinical imaging. EndoScreener functions as a real-time computer-aided detection device for colorectal polyps, providing immediate assistance to physicians.
Physician Tip

For physicians, Chengdu Wision Medical Device's EndoScreener offers a powerful real-time assistant during colonoscopies, significantly improving polyp and adenoma detection rates and reducing the miss rate of precancerous lesions. While the AI provides visual and auditory alerts, it's crucial to remember that the system is intended to assist, not replace, the physician's medical judgment for confirming findings. The high compatibility and easy deployment of the software make it a practical addition to most existing endoscopy setups. Furthermore, their advancements in histopathology with AI-assisted HGD localization and 3D tumor reconstruction (PathoCruz 3D) promise to enhance diagnostic precision and streamline post-procedure assessments, ultimately contributing to better colorectal cancer screening and prevention.

Wision A.I.'s EndoScreener is designed as a software-only medical device (SaMD) that exhibits high compatibility with most mainstream endoscope systems. This allows for flexible deployment in various clinical environments without requiring extensive hardware overhauls. The system analyzes colonoscopy video streams in real-time, providing output directly overlaid onto the images.

Products by Chengdu Wision Medical Device

1 product in the directory

EndoScreener
Chengdu Wision Medical Device Co.
Gastroenterology AI
EndoScreener is an FDA-cleared AI-assisted polyp detection software that provides real-time visual and audible alerts for potential colorectal polyps during colonoscopy procedures.

What the Web Says

Chengdu Wision Medical Device Co., LTD, operating as Wision A.I., is a healthcare AI company that specializes in advanced diagnostic algorithms and systems, particularly for the detection of colorectal polyps. Their product, EndoScreener, is a computer-assisted detection device that analyzes colonoscopy video streams in real-time to highlight potential polyps with blue boxes and can also sound an alert. The EndoScreener has received FDA clearance and has been evaluated in multi-center clinical trials, demonstrating expected polyp detection accuracy and no significant imaging degradation or latency. The company's technology is noted for its use of deep learning and machine learning in medical imaging to enhance diagnostic accuracy and aid clinicians.

Overall: Positive

Strengths

  • Automatically detects polyps using deep learning.
  • Real-time analysis of colonoscopy video streams.
  • Provides visual highlights (bounding boxes) and audio alerts for polyp detection.
  • Demonstrated expected polyp detection accuracy in clinical trials.
  • No significant imaging degradation or latency.
  • FDA-cleared device.

Limitations

  • Device is not intended for diagnosis or characterization of lesions, and does not replace clinical decision-making.
  • Morphological evidence alone may not reveal molecular causes of illnesses or discriminate disease states with similar appearances.
  • Limited information available on employer reviews or general company sentiment outside of product efficacy.

Based on reviews from: accessdata.fda.gov, American Journal of Gastroenterology, HealthAidb u2014 Software, Innolitics, Mazor Robotics - Physician Ai Tools, Novel research and future prospects of artificial intelligence in cancer diagnosis and treatment - PMC, The utility of artificial intelligence in visualization of pediatric gastrointestinal mucosa

Last updated: 2026-07-18

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Press & Coverage

Orthogonal
SaMD Cleared by the FDA: The Ultimate Running List
Chengdu Wision Medical Device Co., Ltd. is listed among companies with FDA-cleared Software as a Medical Device (SaMD) for its EndoScreener, approved on November 19, 2021, for Gastroenterology/Urology. This list compiles 603 individual SaMDs cleared by the FDA, drawing from publicly available sources.
2024-10
U.S. Food & Drug Administration (FDA)
510(k) Premarket Notification: EndoScreener (K211326)
The FDA issued a 510(k) premarket notification for Chengdu Wision Medical Device Co., LTD.'s EndoScreener on November 19, 2021. The EndoScreener is a Class II device, a computer-aided detection software for colorectal polyps, intended to assist clinicians during colonoscopy examinations.
2021-11
American Journal of Gastroenterology
Video Endoscopy as Big Data: Balancing Privacy and Progress in Gastroenterology
This article references Chengdu Wision Medical Device Co., LTD.'s EndoScreener FDA 510(k) premarket notification (K211326) in the context of AI/ML and big data in GI endoscopy. It highlights the device's role in automatically detecting polyps and its classification as a Software as a Medical Device (SaMD).
2023-11
ThinkChina.sg
China's strides in AI: Promising but not without its challenges
Chengdu Wision Medical Device Co. Ltd. is mentioned as one of the Chinese companies that have received approvals for AI-assisted diagnostic software for colonic polyps. This highlights China's advancements in applying deep learning to the medical field to improve polyp detection rates.
2023-07
Journal of Hematology & Oncology
Novel research and future prospects of artificial intelligence in cancer diagnosis and treatment
Chengdu Wision Medical Device Co., LTD's EndoScreener is cited as an FDA-approved AI model for automatically detecting polyps, based on a prospective, multicenter, single-blind randomized tandem colonoscopy study. The article reviews new AI approaches in oncology, including early screening and diagnosis.
2023-11
Medium (by Saim Liaqat Ali)
Problems of Healthcare, Artificial Intelligence and Future of Diagnostics
The EndoScreener by Chengdu Wision Medical Device Co., LTD. is described as a standalone software for real-time automatic detection of polyps in colonoscopy video streams. This article discusses the growing number of FDA-approved AI/ML-enabled medical devices and their applications in diagnostics.
2023-01
Frontiers in Pediatrics
The utility of artificial intelligence in visualization of pediatric gastrointestinal mucosa
Chengdu Wision Medical Device Co. is mentioned with a November 2021 entry for their device in a list of computer-aided detection (CADe) systems. The article discusses the rapid adoption of AI in healthcare, particularly in gastroenterology, for enhancing lesion detection and characterization.
2026-01
Stanford Law School
Decoding U.S. Tort Liability in Healthcare's Black-Box AI Era: Lessons from the European Union
This legal analysis references the FDA's November 19, 2021, letter to Chengdu Wision Medical Device Co., Ltd. regarding their EndoScreener. It discusses the regulatory landscape for AI/ML-based medical devices and potential liability issues in healthcare.
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Frequently Asked Questions

Chengdu Wision Medical Device's AI-powered EndoScreener system is designed to provide real-time assistance during colonoscopy by offering visual and audible alerts for polyp detection, aiming to improve the adenoma detection rate and reduce the miss rate of precancerous lesions. This software-only medical device (SaMD) is compatible with most mainstream endoscope systems, allowing for flexible deployment and seamless integration into current clinical workflows.
Chengdu Wision Medical Device's flagship product is EndoScreener, an AI-assisted polyp detection software for gastrointestinal endoscopy, specifically colonoscopy. Beyond endoscopy, the company is also developing AI software for colorectal histopathology, which assists in locating high-grade dysplasia (HGD) colon polyps in whole slide imaging.
Wision AI's EndoScreener has received CE Mark approval (Class II under the new Medical Devices Regulation, MDR 2017/745) and FDA 510(k) clearance. Its efficacy in improving adenoma detection has been demonstrated in multiple randomized controlled trials involving over 5,000 patients, showing a significant reduction in precancerous lesion miss rates.
While specific details on training and support were not extensively detailed in public search results, as a medical device company, Chengdu Wision typically provides comprehensive training for clinical staff to ensure proper utilization of their systems. Data privacy and security are paramount in healthcare AI, and their systems are designed to comply with relevant data protection regulations to safeguard patient information.
Chengdu Wision's AI tools primarily enhance the initial detection phase during endoscopy, leading to more targeted biopsy sampling. Furthermore, they are developing AI software specifically for histopathology to assist in the localization of high-grade dysplasia (HGD) in whole slide imaging, which can improve the diagnostic accuracy for colorectal cancer.
EndoScreener is described as a software-only medical device (SaMD) that can run on proper off-the-shelf computer hardware, contributing to a relatively economical total cost of ownership (TCO). Pricing models typically involve the software license, and the overall cost for healthcare facilities would include the initial software acquisition and any necessary compatible hardware.
Wision AI is a startup focused on AI-assisted diagnostics for gastrointestinal endoscopy, demonstrating growth through regulatory approvals and clinical validation. They have established partnerships, such as with Micro-Tech Endoscopy USA, which serves as the U.S. GI endoscopy distributor for EndoScreener, indicating a strategy for market expansion and product accessibility.

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