EndoScreener

JSON twin: https://www.healthaidb.com/software/endoscreener.json

Company Name

Chengdu Wision Medical Device Co.

Product URL

https://www.wisionmed.com

Company URL

https://www.wisionmed.com

Categories

• clinical Care
• diagnostic Support
• patient Facing
• Clinical
• Diagnostic

Summary

EndoScreener is an AI-assisted software developed by Chengdu Wision Medical Device Co. to enhance polyp detection during colonoscopy procedures, aiming to improve early colorectal cancer detection rates.

Description

EndoScreener is a computer-assisted detection software that automatically identifies and highlights potential polyps during colonoscopy procedures. It processes the live video feed from the colonoscope and overlays blue boxes on suspected polyps, alerting the physician in real-time to improve polyp detection and assist clinical decision-making during colonoscopy in adults. The device's deep learning algorithm was validated on multiple datasets, including 1,138 polyp patients with histological confirmation, showing expected sensitivity and specificity. Clinical performance was assessed in a multi-center randomized controlled trial with 223 patients, demonstrating significantly lower adenoma miss rates and higher adenomas per colonoscopy when using EndoScreener. The device caused no imaging degradation and minimal latency. EndoScreener is compatible with most mainstream endoscope systems and can be deployed with high flexibility in various clinical environments for colonoscopy.

Api Available

unknown

Certifications

• FDA 510(k)
• CE-MDR
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 62366
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20
• IEC 60601-1-21
• IEC 60601-1-22
• IEC 60601-1-23
• IEC 60601-1-24
• IEC 60601-1-25

Company Founding

2019

Company Offices

• China
• United States
• European Union

Compliance

• FDA 510(k)
• CE-MDR
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 62366
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20
• IEC 60601-1-21
• IEC 60601-1-22
• IEC 60601-1-23
• IEC 60601-1-24
• IEC 60601-1-25

Customers

Data Residency

US/EU regions

Data Standards

• DICOM

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Real-time automatic polyp detection during colonoscopy
• Visual notifications and sound alarms for polyp detection
• Compatible with most mainstream endoscope systems
• Software-only medical device with economical total cost of ownership
• High flexibility in deployment across various clinical environments

Id

SW0439

Integration Partners

Integrations

• Endoscope systems
• Colonoscopy video streams

Languages Supported

• English
• Chinese

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• Histopathology AI software for high-grade dysplasia localization

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0439

Product Name

EndoScreener

Ratings

Regions Available

• United States
• European Union
• China

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Encryption
• RBAC
• SSO/SAML
• Audit logs
• 2FA
• DLP

Specialties

• Gastroenterology
• Colorectal Surgery

Support Channels

System Requirements

Standard computer hardware compatible with endoscope systems

Target Users

• Clinicians
• Nurses
• Admins

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "EndoScreener",
  "company_name": "Chengdu Wision Medical Device Co.",
  "product_url": "https://www.wisionmed.com",
  "company_url": "https://www.wisionmed.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0439",
  "summary": "EndoScreener is an AI-assisted software developed by Chengdu Wision Medical Device Co. to enhance polyp detection during colonoscopy procedures, aiming to improve early colorectal cancer detection rates.",
  "description": "EndoScreener is a computer-assisted detection software that automatically identifies and highlights potential polyps during colonoscopy procedures. It processes the live video feed from the colonoscope and overlays blue boxes on suspected polyps, alerting the physician in real-time to improve polyp detection and assist clinical decision-making during colonoscopy in adults. The device's deep learning algorithm was validated on multiple datasets, including 1,138 polyp patients with histological confirmation, showing expected sensitivity and specificity. Clinical performance was assessed in a multi-center randomized controlled trial with 223 patients, demonstrating significantly lower adenoma miss rates and higher adenomas per colonoscopy when using EndoScreener. The device caused no imaging degradation and minimal latency. EndoScreener is compatible with most mainstream endoscope systems and can be deployed with high flexibility in various clinical environments for colonoscopy.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Patient-facing"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Clinicians",
    "Nurses",
    "Admins"
  ],
  "specialties": [
    "Gastroenterology",
    "Colorectal Surgery"
  ],
  "regions_available": [
    "United States",
    "European Union",
    "China"
  ],
  "languages_supported": [
    "English",
    "Chinese"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "China",
    "United States",
    "European Union"
  ],
  "company_founding": "2019",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Real-time automatic polyp detection during colonoscopy",
    "Visual notifications and sound alarms for polyp detection",
    "Compatible with most mainstream endoscope systems",
    "Software-only medical device with economical total cost of ownership",
    "High flexibility in deployment across various clinical environments"
  ],
  "optional_modules": [
    "Histopathology AI software for high-grade dysplasia localization"
  ],
  "integrations": [
    "Endoscope systems",
    "Colonoscopy video streams"
  ],
  "data_standards": [
    "DICOM"
  ],
  "api_available": "unknown",
  "system_requirements": "Standard computer hardware compatible with endoscope systems",
  "compliance": [
    "FDA 510(k)",
    "CE-MDR",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "IEC 62366",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20",
    "IEC 60601-1-21",
    "IEC 60601-1-22",
    "IEC 60601-1-23",
    "IEC 60601-1-24",
    "IEC 60601-1-25"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE-MDR",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "IEC 62366",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20",
    "IEC 60601-1-21",
    "IEC 60601-1-22",
    "IEC 60601-1-23",
    "IEC 60601-1-24",
    "IEC 60601-1-25"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0439",
  "slug": "endoscreener",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/endoscreener.json"
  }
}