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, also known as Wision A.I., is a healthcare AI company focused on transforming clinical practice through digital health innovations. They specialize in developing computer-aided diagnosis (CAD) algorithms and systems for clinical imaging to improve diagnostic accuracy and effectiveness. Their flagship product, EndoScreener, is an AI-powered software designed for real-time automatic detection of polyps during colonoscopy procedures. It processes live video feeds from colonoscopes and overlays visual alerts on suspected polyps, aiming to enhance polyp detection and support clinical decision-making for endoscopists.

Wision A.I. integrates medical knowledge into scalable models using advanced convolutional neural networks. The EndoScreener has received regulatory clearances, including FDA 510(k) clearance in November 2021 and CE Mark Class II approval under the new Medical Devices Regulation (MDR 2017/745) in November 2021. Clinical studies have demonstrated its efficacy in improving adenoma detection rates. Beyond gastrointestinal endoscopy, Wision A.I. is also involved in histopathology, with efforts in whole slide localization of cancerous regions in Whole Slide Imaging (WSI).

Focus Areas

Gastrointestinal endoscopy AI-assisted diagnosis medical imaging deep learning early cancer detection

Business Intelligence

TechnologyCloud-native AI platform, deep learning algorithms for real-time image analysis

What Physicians Need to Know

AI-assisted Diagnostics
Chengdu Wision Medical Device (Wision A.I.) specializes in AI-assisted diagnostics, particularly with their flagship product, EndoScreener, for real-time polyp detection during colonoscopies. They also develop AI software for colorectal histopathology, assisting in locating high-grade dysplasia (HGD) colon polyps in whole slide imaging.
Optical Medical Imaging & Gastrointestinal Endoscopy
The company develops computer-aided diagnosis (CAD) algorithms and systems for clinical imaging, specifically in optical medical imaging modalities like endoscopy. Their EndoScreener system is designed to provide real-time assistance during colonoscopy by offering visual and audible alerts for polyp detection.
Histopathology
Wision A.I. is actively developing AI software for colorectal histopathology, which aids in locating high-grade dysplasia (HGD) colon polyps in whole slide imaging. They have also launched PathoCruz 3D, an automated histological 3D reconstruction tool to reveal tumor spatial characteristics.
Colorectal Cancer Screening & Polyp Detection
A core specialization is colorectal cancer screening and polyp detection. Their EndoScreener software significantly increases adenoma and polyp detection rates during colonoscopies, aiming to improve the adenoma detection rate and reduce the miss rate of precancerous lesions.
Computer-Aided Diagnosis (CAD)
Wision A.I. builds Computer-Aided Diagnosis (CAD) algorithms and systems in clinical imaging to improve diagnostic accuracy and effectiveness. Their EndoScreener is a computer-assisted detection (CADe) software.
Key Differentiators
Wision A.I.'s EndoScreener has received CE Mark approval (Class II under the new Medical Devices Regulation, MDR 2017/745) and FDA 510(k) clearance. It has demonstrated efficacy in improving adenoma detection on over 5,000 patients in six rigorous randomized controlled trials. The company emphasizes solving problems with small datasets and respects the mathematical essence of deep learning.
Technology Stack
Their technology leverages cutting-edge convolutional neural networks and general-purpose computing. The EndoScreener uses a deep learning algorithm based on SegNet architecture. They integrate medical knowledge into flexible and scalable models.
Physician Tip

For physicians, Chengdu Wision Medical Device's EndoScreener offers real-time AI-assisted polyp detection during colonoscopies, providing visual and audible alerts that can significantly improve adenoma detection rates and reduce the miss rate of precancerous lesions. The software is compatible with most mainstream endoscope systems, allowing for flexible integration into existing clinical workflows. While the AI assists in identification, physicians remain responsible for confirming findings based on their medical judgment. Their histopathology tools, like PathoCruz 3D, are designed to enhance diagnostic precision by providing 3D renderings of tissue samples, offering a more comprehensive view of tumors. This can aid in personalized treatment plans and automate post-procedure pathological assessments.

The EndoScreener is a software-only medical device (SaMD) compatible with most mainstream endoscope systems, allowing for flexible deployment and seamless integration into current clinical workflows. It processes live video feed from the colonoscope and overlays blue boxes on suspected polyps. The system can be deployed with appropriate hardware in mainstream computers.

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. is a healthcare AI company that develops gastroenterology AI tools for physicians, with a focus on computer-aided detection software for colorectal polyps. Their product, EndoScreener, is designed to assist physicians in real-time identification of suspect polyps during colonoscopies. The company's products have received marketing approval in China and FDA clearance in the United States. While there is information available on their product's efficacy and regulatory status, there is limited public information regarding employer reviews or general company sentiment outside of product performance.

Overall: Mixed

Strengths

  • Computer-aided detection of colorectal polyps
  • Assists physicians in real-time during colonoscopies
  • Utilizes deep learning models for high performance
  • Approved for marketing in China
  • FDA cleared in the United States
  • Potential for earlier detection of precancerous lesions

Limitations

  • Limited information on employer or general company reviews
  • Product not intended for diagnosis or characterization of lesions
  • Does not replace clinical decision-making
  • Morphological evidence alone may not reveal molecular causes of illnesses

Based on reviews from: Physician AI Tools, NMPA (China National Medical Products Administration), PubMed Central, Innolitics, accessdata.fda.gov, HealthAidb — Software

Last updated: 2026-10-19

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Press & Coverage

FDA
510(k) Premarket Notification - EndoScreener
Chengdu Wision Medical Device Co., Ltd. received 510(k) premarket notification for their EndoScreener device, a computer-aided detection software for colorectal polyps. The FDA determined the device is substantially equivalent to legally marketed predicate devices.
2026-10
MobiHealthNews
Chinese startup gets CE mark for AI polyp detection tool
Shanghai-based startup Wision AI received Europe's CE mark for its AI-enabled polyp detection software, EndoScreener, used in colonoscopy. The software assists endoscopists by providing real-time notifications and alarms when a polyp is detected.
2021-11
Fierce Biotech
Wision A.I. secures FDA nod for polyp-spotting colonoscopy tech
Wision A.I. received FDA 510(k) clearance for its EndoScreener, an artificial intelligence software system designed to identify potentially precancerous polyps during colonoscopy. This marks the company's first FDA clearance, with plans for another AI-based tool for histopathological diagnosis.
2022-03
Wision A.I.
NMPA Class III Approval for EndoScreener
Wision A.I.'s EndoScreener received Class III approval from the National Medical Products Administration (NMPA) through the Innovative Medical Device Special Approval Procedure. This approval signifies a significant regulatory milestone for the company in China.
2022-08
Wision A.I.
CE-MDR Mark (Class II) for EndoScreener
Wision A.I. announced receiving the CE-MDR Mark (Class II) for its EndoScreener, making it the first CE Mark Class II Certificate of CADe Tools for Colonoscopy under the new Medical Devices Regulation (MDR 2017/745).
2022-08
Medlatest - Medical Device News
AI Increases Polyp Detection During Colonoscopy
Wision AI published data from the first prospective, randomized controlled trial evaluating AI in advanced diagnostics, showing its system significantly increased adenoma and polyp detection rates during colonoscopy. The study was conducted in 1,058 patients.
2019-03
Wision A.I.
PathoCruz 3D:An Automated Histological 3D Reconstruction Tool
Wision A.I. released a press release introducing PathoCruz 3D, an automated histological 3D reconstruction tool. This tool aims to reveal tumor spatial characteristics, representing an advancement in histology.
2022-08
Shenzhen Daily
RMB 2 billion medical device fund lands in Longhua
A 2-billion-yuan (US$281 million) investment fund targeting high-end medical devices has been established in Longhua, Shenzhen. While not directly about Chengdu Wision Medical Device, this indicates a strong funding environment for medical device companies in China.
2026-09

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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