EndoScreener
by Chengdu Wision Medical Device Co.
· Based in China →
— AI-assisted real-time polyp detection for colonoscopy
Contact vendor for pricing details.
Regulatory Status Disclosed
Overview
EndoScreener, developed by Chengdu Wision Medical Device Co. (also known as Wision A.I.), is a computer-assisted detection (CADe) device designed to aid endoscopists in the real-time identification of colorectal polyps during colonoscopy procedures. The software analyzes the colonoscopy video stream and provides visual notifications, such as blue bounding boxes, to highlight regions of potential polyps. It also offers an optional sound alert for detected polyps. EndoScreener is intended to supplement, not replace, the physician’s medical judgment and is indicated for use by licensed endoscopists performing white light colonoscopy in adults. It functions as a stand-alone software medical device (SaMD) compatible with most mainstream endoscope systems.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Real-time automatic detection of colorectal polyps
- Computer-assisted detection (CADe) technology
- Visual notification with blue bounding boxes for potential polyps
- Optional sound alert for polyp detection
- Analyzes colonoscopy video streams in real-time
- Compatible with most mainstream endoscope systems
- Software-only medical device (SaMD)
- Demonstrated efficacy in improving adenoma detection rate in clinical trials
Use Cases
- Aiding endoscopists during colonoscopy procedures
- Improving the detection rate of colorectal polyps
- Reducing the miss rate of precancerous lesions
- Supporting colorectal cancer prevention efforts
- Enhancing the accuracy of colorectal cancer screening
What Physicians Need to Know
Polyp Detection During Colonoscopy
EndoScreener is an AI-assisted software that provides real-time visual notifications and sound alarms for polyp detection during colonoscopy. It has been shown to reduce the precancerous lesion miss rate by 41% and improve adenoma per colonoscopy (APC) by 33%. The system has a per-image sensitivity of 94.38% and specificity of 95.92% for detecting colon polyps.
Real-Time Endoscopy AI
The tool functions as a real-time diagnosis software, processing each frame of the colonoscopy video stream synchronously. It provides visual alerts, such as a hollow alert box on the endoscopy screen, and a simultaneous alarm sound when a potential polyp is detected.
Adenoma Detection Rate Improvement
EndoScreener has demonstrated efficacy in improving adenoma detection in over 5,000 patients across six randomized controlled trials. Studies indicate it can increase adenoma detection by 32% to 33% and reduce the adenoma miss rate by 41%. This improvement was observed even in populations with high average adenoma detection rates (ADR), suggesting no ceiling effect.
Quality Metrics Tracking
By significantly improving the Adenoma Detection Rate (ADR) and reducing the polyp miss rate, EndoScreener directly contributes to key quality metrics in colonoscopy.
Endoscopy System Compatibility
EndoScreener is designed as a software-only medical device (SaMD) that is compatible with most mainstream endoscope systems. It can be deployed in various clinical environments for colonoscopy using proper off-the-shelf computer hardware.
Physician Tip
Endoscopists should utilize EndoScreener as a 'second observer' to augment their detection capabilities during colonoscopy, leveraging its real-time visual and auditory alerts to identify polyps that might otherwise be missed. While the AI significantly improves detection rates, clinical judgment remains paramount for confirming findings and guiding patient management. The tool is effective for both experienced and less experienced endoscopists in improving ADR.
EndoScreener is a software-only medical device (SaMD) that integrates into existing colonoscopy workflows. It is compatible with most mainstream endoscope systems and requires standard off-the-shelf computer hardware for deployment, making it adaptable to various clinical settings.
Details
| Category | Gastroenterology AI |
| Pricing | Contact vendor for pricing details. — Contact vendor |
| Deployment | Software-only medical device (SaMD) that can be deployed with off-the-shelf computer hardware in various clinical environments for colonoscopy. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated EndoScreener received FDA 510(k) clearance (K211326) on November 19, 2021. It is cleared as a computer-assisted detection device for colorectal polyps, intended as stand-alone software for real-time automatic detection during colonoscopy. |
| Integrations | |
| EHR | Not specified |
| Specialties | Colorectal Surgery, Gastroenterology |
What the Web Says
EndoScreener is an AI-assisted polyp detection software developed by Wision AI that has received FDA 510(k) clearance in November 2021 and CE mark class II certification at the end of 2021. It is designed to improve the detection of adenomas during colonoscopy procedures. Studies have shown that EndoScreener can significantly reduce the adenoma miss rate and increase the adenoma detection rate, even for experienced physicians.
Overall: PositiveStrengths
- Significantly reduces the adenoma miss rate (by 35.6% in one study).
- Increases the adenoma detection rate (by 32.2% in one study, and a 72% relative increase in the number of adenomas per colonoscopy).
- Potential to decrease variability in colonoscopy quality among providers.
- Supports colonoscopy as the gold standard for colorectal cancer screening and prevention.
- Commercially available in the U.S. through partners.
- Demonstrated efficacy in over 5,000 patients in six randomized controlled trials.
Limitations
- Ranked just above the control group in a network meta-analysis comparing various AI-assisted systems for adenoma detection, suggesting other systems may offer higher efficacy.
- No significant improvement in the detection of high-risk lesions compared to conventional colonoscopy.
- Performance differences among AI systems are modest, and detection of high-risk lesions remains uncertain.
- One Reddit user expressed mixed feelings about AI tools in general, noting they may find more tiny polyps that don't clinically matter and could decrease interval times.
Based on reviews from: BioWorld, PubMed Central (PMC), Becker's ASC, Reddit
Last updated: 2026-07-17
Ratings & Reviews
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Press & Coverage
NS Medical Devices
Wision AI gets CE Mark approval for AI-powered endoscopy software EndoScreener
Wision AI secured CE Mark approval for its AI-assisted polyp detection software, EndoScreener, making it the first solution to receive a CE Mark class II certificate under the new Medical Devices Regulation, MDR 2017/745. The device has shown efficacy in improving adenoma detection in over 5,000 patients across six randomized controlled trials.
2021-11
Fierce Biotech
Wision A.I. secures FDA nod for polyp-spotting colonoscopy tech | Fierce Biotech
Wision A.I. received FDA 510(k) clearance for EndoScreener, an AI software system designed to identify potentially precancerous polyps during colonoscopy. This approval followed its European CE mark approval and was based on a clinical study demonstrating a reduction in missed polyps.
2022-03
PR Newswire UK
Wision A.I. Achieves CE-MDR Mark Approval for AI-assisted Diagnostic Software Medical Device Supporting Colonoscopy - PR Newswire UK
Wision A.I. Ltd announced it received European CE Mark approval for EndoScreener, its AI-assisted polyp detection software for colonoscopy, marking it as the first CE Mark class II certificate under the new Medical Devices Regulation (MDR 2017/745). The company highlighted EndoScreener's strong clinical evidence from over 5000 patients in six randomized controlled trials.
2021-11
GlobeNewswire
World's First External Independent Randomized Controlled Trial of Artificial Intelligence Demonstrates More Accurate Colonoscopy Screening and Surveillance Utilizing Wision AI's Technology Compared to the Standard of Care - GlobeNewswire
Wision AI announced the publication of data from the world's first external independent randomized controlled trial of its EndoScreener system, demonstrating positive results in reducing adenoma miss rates and increasing adenomas detected per colonoscopy. The trial data was published in Clinical Gastroenterology & Hepatology.
2021-09
BioWorld
Wision AI expands US screening offerings to combat colorectal cancer | BioWorld
Following FDA clearance of its EndoScreener AI-assisted polyp detection software, Wision AI Ltd. is expanding its product portfolio to include colorectal histopathology tools. The EndoScreener increased adenoma detection by 32.2% and reduced the adenoma miss rate by 35.6% in a multi-center randomized controlled trial.
2022-04
Becker's ASC Review
2 tech companies partner to distribute AI polyp detection for colonoscopies - Becker's ASC
Micro-Tech Endoscopy USA and Wision A.I. partnered to make Micro-Tech the U.S. GI endoscopy distributor of Wision's EndoScreener, an artificial intelligence-assisted polyp detection software. EndoScreener received FDA clearance in November and was shown to identify about 32 percent more adenomas than standard colonoscopies.
2022-05
accessdata.fda.gov
November 19, 2021 Chengdu Wision Medical Device Co., LTD. John Smith Partner Hogan Lovells US LLP 555 Thirteenth St, NW Wash - accessdata.fda.gov
This FDA 510(k) summary details the EndoScreener device, a computer-assisted detection software for colorectal polyps, intended for real-time automatic detection during colonoscopy. It outlines the device's description, indications for use, and regulatory classification as a Class II medical device.
2021-11
pharmaphorum
NICE backs five AI tools for bowel cancer screening - pharmaphorum
New guidance from NICE has recommended five AI tools, including Wision AI's EndoScreener, for use in the NHS to detect colorectal polyps. These tools can be used over the next four years to gather more evidence on their benefits in spotting and characterizing polyps.
2025-11
Videos
Product demos, reviews, and walkthroughs for EndoScreener.
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Frequently Asked Questions
EndoScreener is designed for seamless integration, typically connecting to your existing endoscopy system to provide real-time analysis during procedures. It primarily supports colonoscopy, aiding in polyp detection by providing visual and sound alerts.
Yes, EndoScreener has received FDA clearance as an AI-assisted polyp detection software for colonoscopy. It ensures patient data privacy by adhering to HIPAA regulations, which require robust encryption, access controls, and often a Business Associate Agreement with the vendor if PHI is processed.
While highly accurate, EndoScreener, like other AI tools, has reported false positive and negative rates, which vary by lesion type. It is explicitly designed as an assistive tool to enhance physician detection and reduce miss rates, not to replace the critical role of human interpretation and decision-making.
EndoScreener has demonstrated superior adenoma detection rates (ADRs) compared to traditional manual screening and appears to outperform most other endoscopic interventions in improving ADRs. Its efficiency gains come from real-time analysis, which can reduce procedure time and improve diagnostic consistency.
Pricing models for healthcare AI solutions like EndoScreener often include tiered subscriptions based on usage volume or a fixed cost for well-defined projects. While EndoScreener is primarily software-only, some installations may require proper off-the-shelf computer hardware or network upgrades, which would be discussed during implementation.
Physicians remain ultimately responsible for patient care and diagnostic decisions, as AI tools like EndoScreener are decision-support aids. Legal frameworks are evolving, but providers are expected to exercise independent clinical judgment and ensure informed consent when AI is used in diagnosis.
EndoScreener was trained on large datasets of endoscopic images and validated through extensive multi-center randomized controlled trials involving thousands of patients. Detailed performance reports, including sensitivity, specificity, and adenoma detection rates, are available, demonstrating its efficacy in improving polyp detection.
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| Last Verified: 2026-04-18 | First Added: 2026-04-18