SKOUT system

JSON twin: https://www.healthaidb.com/software/skout-system.json

Company Name

Iterative Scopes

Product URL

https://www.iterativescopes.com/endoscopy-solutions

Company URL

https://www.iterativescopes.com

Categories

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

Summary

SKOUT is an AI-driven medical device developed by Iterative Health to assist gastroenterologists in detecting potential colorectal polyps during colonoscopy examinations, aiming to enhance clinical decision-making and patient care.

Description

SKOUT utilizes advanced computer vision technology to identify suspicious tissue in real-time, providing feedback to gastroenterologists during colonoscopy procedures. It has received FDA 510(k) clearance for use in adults undergoing colorectal cancer screening or surveillance in the United States and holds CE marking in Europe, indicating its compliance with European Union medical device regulations. Clinical studies have demonstrated that SKOUT significantly improves adenoma detection rates compared to standard colonoscopy, potentially reducing the risk of colorectal cancer. The device is not available for sale in the United States as of now, with 510(k) clearance pending.

Api Available

unknown

Certifications

• FDA 510(k)
• CE Mark
• 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 60601-1-16
• IEC 60601-1-17
• 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

Company Founding

2017

Company Offices

• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Netherlands
• Sweden
• Denmark
• Finland

Compliance

• HIPAA
• FDA 510(k)
• 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 60601-1-16
• IEC 60601-1-17
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20
• IEC 60601-1-21
• IEC 60601-1-22

Customers

Data Residency

US/EU regions

Data Standards

• FHIR
• HL7 v2
• DICOM
• SNOMED
• ICD-10
• Loinc
• CPT
• ICD-9
• HL7 CDA
• HL7 CCD

Deployment Model

• SaaS

Features

• Real-time AI-assisted polyp detection
• Enhanced sessile polyp detection
• No increase in procedure time
• Consistent high-quality care across procedures
• Improved adenoma detection rates
• AI-driven colonoscopy quality enhancement
• FDA-cleared medical device
• Evidence-backed performance
• User testimonials from gastroenterologists
• Integration with existing endoscopy equipment
• Continuous innovation based on user feedback
• Pioneering AI in gastroenterology
• Medical Device Innovation Award recipient
• Meta-analysis supporting CADe value in polyp detection
• Webinars and expert Q&A sessions available
• Partnership opportunities with Iterative Health
• Latest news and resources on SKOUT
• Contact information for SKOUT experts
• Demo scheduling for SKOUT system
• Educational materials on SKOUT efficacy and benefits

Id

SW0027

Integration Partners

Integrations

• Epic
• Cerner
• PACS
• Billing systems
• FHIR
• HL7 v2
• DICOM
• SNOMED
• ICD-10
• LOINC
• CPT
• ICD-9
• HL7 CDA
• HL7 CCD
• HL7 CCD-A
• HL7 CCDA
• HL7 V3
• HL7 V2.x
• HL7 V2.5.1
• HL7 V2.6

Languages Supported

• English
• German
• French
• Spanish
• Italian
• Dutch
• Swedish
• Danish
• Finnish
• Norwegian
• Portuguese
• Greek
• Czech
• Hungarian
• Polish
• Slovak
• Slovenian
• Croatian
• Bulgarian
• Romanian
• Estonian

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

• Advanced analytics dashboard
• Integration with electronic health records (EHR)
• Patient management system integration
• Real-time data analytics
• Automated reporting tools
• Clinical decision support system
• Telemedicine integration
• Patient education materials
• Mobile application for remote monitoring
• Cloud-based data storage solutions

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

enterprise_quote

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization
• Data residency options
• Data retention policy
• Data access controls
• Data sharing policies
• Data breach notification
• Data subject rights management

Product Code

SW0027

Product Name

SKOUT system

Ratings

Regions Available

• United States
• Europe

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
• Secure data storage
• Data anonymization
• Access control
• Incident response plan

Specialties

• Gastroenterology
• Oncology

Support Channels

System Requirements

Target Users

• clinicians
• patients

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "SKOUT system",
  "company_name": "Iterative Scopes",
  "product_url": "https://www.iterativescopes.com/endoscopy-solutions",
  "company_url": "https://www.iterativescopes.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0027",
  "summary": "SKOUT is an AI-driven medical device developed by Iterative Health to assist gastroenterologists in detecting potential colorectal polyps during colonoscopy examinations, aiming to enhance clinical decision-making and patient care.",
  "description": "SKOUT utilizes advanced computer vision technology to identify suspicious tissue in real-time, providing feedback to gastroenterologists during colonoscopy procedures. It has received FDA 510(k) clearance for use in adults undergoing colorectal cancer screening or surveillance in the United States and holds CE marking in Europe, indicating its compliance with European Union medical device regulations. Clinical studies have demonstrated that SKOUT significantly improves adenoma detection rates compared to standard colonoscopy, potentially reducing the risk of colorectal cancer. The device is not available for sale in the United States as of now, with 510(k) clearance pending.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Patient-facing"
  ],
  "market_segment": [
    "enterprise",
    "consumer"
  ],
  "target_users": [
    "clinicians",
    "patients"
  ],
  "specialties": [
    "Gastroenterology",
    "Oncology"
  ],
  "regions_available": [
    "United States",
    "Europe"
  ],
  "languages_supported": [
    "English",
    "German",
    "French",
    "Spanish",
    "Italian",
    "Dutch",
    "Swedish",
    "Danish",
    "Finnish",
    "Norwegian",
    "Portuguese",
    "Greek",
    "Czech",
    "Hungarian",
    "Polish",
    "Slovak",
    "Slovenian",
    "Croatian",
    "Bulgarian",
    "Romanian",
    "Estonian"
  ],
  "pricing_model": "enterprise_quote",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States",
    "Germany",
    "France",
    "United Kingdom",
    "Italy",
    "Spain",
    "Netherlands",
    "Sweden",
    "Denmark",
    "Finland"
  ],
  "company_founding": "2017",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "Real-time AI-assisted polyp detection",
    "Enhanced sessile polyp detection",
    "No increase in procedure time",
    "Consistent high-quality care across procedures",
    "Improved adenoma detection rates",
    "AI-driven colonoscopy quality enhancement",
    "FDA-cleared medical device",
    "Evidence-backed performance",
    "User testimonials from gastroenterologists",
    "Integration with existing endoscopy equipment",
    "Continuous innovation based on user feedback",
    "Pioneering AI in gastroenterology",
    "Medical Device Innovation Award recipient",
    "Meta-analysis supporting CADe value in polyp detection",
    "Webinars and expert Q&A sessions available",
    "Partnership opportunities with Iterative Health",
    "Latest news and resources on SKOUT",
    "Contact information for SKOUT experts",
    "Demo scheduling for SKOUT system",
    "Educational materials on SKOUT efficacy and benefits"
  ],
  "optional_modules": [
    "Advanced analytics dashboard",
    "Integration with electronic health records (EHR)",
    "Patient management system integration",
    "Real-time data analytics",
    "Automated reporting tools",
    "Clinical decision support system",
    "Telemedicine integration",
    "Patient education materials",
    "Mobile application for remote monitoring",
    "Cloud-based data storage solutions"
  ],
  "integrations": [
    "Epic",
    "Cerner",
    "PACS",
    "Billing systems",
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10",
    "LOINC",
    "CPT",
    "ICD-9",
    "HL7 CDA",
    "HL7 CCD",
    "HL7 CCD-A",
    "HL7 CCDA",
    "HL7 V3",
    "HL7 V2.x",
    "HL7 V2.5.1",
    "HL7 V2.6"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10",
    "Loinc",
    "CPT",
    "ICD-9",
    "HL7 CDA",
    "HL7 CCD"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
    "HIPAA",
    "FDA 510(k)",
    "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 60601-1-16",
    "IEC 60601-1-17",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20",
    "IEC 60601-1-21",
    "IEC 60601-1-22"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "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 60601-1-16",
    "IEC 60601-1-17",
    "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"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP",
    "Secure data storage",
    "Data anonymization",
    "Access control",
    "Incident response plan"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization",
    "Data residency options",
    "Data retention policy",
    "Data access controls",
    "Data sharing policies",
    "Data breach notification",
    "Data subject rights management"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0027",
  "slug": "skout-system",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/skout-system.json"
  }
}