PAPNET Testing System

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

Company Name

Neuromedical Systems

Product URL

https://neuromedical.com/papnet-testing-system

Company URL

https://neuromedical.com

Categories

• diagnostic Support
• clinical Care
• laboratory Testing
• oncology Care
• Diagnostic
• Clinical
• Laboratory
• Oncology
• Cervical Cancer Screening

Summary

PAPNET Testing System is an AI-driven tool designed to assist cytotechnologists in detecting abnormal cells in Pap smears, enhancing cervical cancer screening accuracy.

Description

PAPNET Testing System utilizes neural network technology to analyze Pap smear slides, identifying potentially abnormal cells for review by cytotechnologists. It was FDA-cleared in 1995 for rescreening previously interpreted negative smears, aiming to reduce false negatives in cervical cancer detection. The system scans slides, selects 128 cells that appear most abnormal, and displays them for focused review. Clinical studies have demonstrated its effectiveness in detecting both benign and malignant glandular elements in cervicovaginal smears. However, its adoption has been limited due to high costs and operational requirements. Neuromedical Systems, Inc., the developer, has since sold the PAPNET system to Finland for use in primary screening of cervical smears.

Api Available

unknown

Certifications

• FDA 510(k)
• CE Mark
• ISO 13485
• 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

1989

Company Offices

• United States
• Finland

Compliance

• HIPAA
• FDA 510(k)
• ISO 13485
• 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

Customers

• Finnish Foundation for Cancer Research

Data Residency

US-only

Data Standards

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

Deployment Model

• on_prem

Features

• Automated cervical smear rescreening
• High-resolution slide scanning
• AI-driven pattern recognition
• Interactive human review interface
• Detection of abnormal epithelial cells
• Reduction of false-negative results
• Clinical validation studies
• FDA clearance for rescreening use
• Integration with laboratory information systems
• User-friendly interface for pathologists
• Support for various slide types
• Real-time processing capabilities
• Comprehensive reporting tools
• Data storage and retrieval functionalities
• Quality control mechanisms
• Compliance with medical device standards
• Scalability for laboratory environments
• Remote diagnostics support
• Regular software updates
• Technical support services

Id

SW0650

Integration Partners

• FDA

Integrations

• Laboratory Information Systems
• Electronic Health Records
• Laboratory Automation Systems
• Cloud Storage Services
• Mobile Devices
• Multilingual Support Systems
• Advanced Image Processing Tools
• Data Visualization Platforms
• Patient Notification Systems
• Remote Diagnostics Platforms

Languages Supported

• English
• Finnish

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise

Optional Modules

• Advanced reporting analytics
• Integration with electronic health records
• Cloud-based data storage
• Automated patient notification system
• Multilingual support
• Customizable user interface themes
• Advanced image processing algorithms
• Integration with laboratory automation systems
• Mobile device compatibility
• Data visualization tools

Os Platforms

• Windows
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

enterprise_quote

Privacy Features

• Business Associate Agreement (BAA)
• Consent Management
• Data Anonymization
• Data Minimization
• Data Masking
• Access Control Policies
• Data Retention Policies
• Data Encryption
• User Privacy Settings
• Compliance with Privacy Regulations

Product Code

SW0650

Product Name

PAPNET Testing System

Ratings

• FDA approved in 1995 under PMA P940029.

Regions Available

• United States
• Finland

Related Urls

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

Release Year

1995

Security Features

• Encryption
• Role-Based Access Control (RBAC)
• Single Sign-On (SSO)
• Audit Logs
• Two-Factor Authentication (2FA)
• Data Loss Prevention (DLP)
• Secure Socket Layer (SSL) Certificates
• Regular Security Patches
• User Activity Monitoring
• Compliance with Security Standards

Specialties

• Oncology
• Cytology
• Pathology

Support Channels

• email
• phone
• chat
• ticketing
• community
• 24x7

System Requirements

Windows Server 2016 or later, Linux (Ubuntu 18.04 or later), 16 GB RAM, 500 GB HDD, 1 Gbps network connection

Target Users

• cytotechnologists
• pathologists
• laboratory technicians

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

• PAPNET system significantly improved detection rates compared to manual screening.

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "PAPNET Testing System",
  "company_name": "Neuromedical Systems",
  "product_url": "https://neuromedical.com/papnet-testing-system",
  "company_url": "https://neuromedical.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0650",
  "summary": "PAPNET Testing System is an AI-driven tool designed to assist cytotechnologists in detecting abnormal cells in Pap smears, enhancing cervical cancer screening accuracy.",
  "description": "PAPNET Testing System utilizes neural network technology to analyze Pap smear slides, identifying potentially abnormal cells for review by cytotechnologists. It was FDA-cleared in 1995 for rescreening previously interpreted negative smears, aiming to reduce false negatives in cervical cancer detection. The system scans slides, selects 128 cells that appear most abnormal, and displays them for focused review. Clinical studies have demonstrated its effectiveness in detecting both benign and malignant glandular elements in cervicovaginal smears. However, its adoption has been limited due to high costs and operational requirements. Neuromedical Systems, Inc., the developer, has since sold the PAPNET system to Finland for use in primary screening of cervical smears.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "laboratory Testing",
    "oncology Care",
    "Diagnostic",
    "Clinical",
    "Laboratory",
    "Oncology",
    "Cervical Cancer Screening"
  ],
  "market_segment": [
    "enterprise"
  ],
  "target_users": [
    "cytotechnologists",
    "pathologists",
    "laboratory technicians"
  ],
  "specialties": [
    "Oncology",
    "Cytology",
    "Pathology"
  ],
  "regions_available": [
    "United States",
    "Finland"
  ],
  "languages_supported": [
    "English",
    "Finnish"
  ],
  "pricing_model": "enterprise_quote",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States",
    "Finland"
  ],
  "company_founding": "1989",
  "deployment_model": [
    "on_prem"
  ],
  "os_platforms": [
    "Windows",
    "Linux"
  ],
  "features": [
    "Automated cervical smear rescreening",
    "High-resolution slide scanning",
    "AI-driven pattern recognition",
    "Interactive human review interface",
    "Detection of abnormal epithelial cells",
    "Reduction of false-negative results",
    "Clinical validation studies",
    "FDA clearance for rescreening use",
    "Integration with laboratory information systems",
    "User-friendly interface for pathologists",
    "Support for various slide types",
    "Real-time processing capabilities",
    "Comprehensive reporting tools",
    "Data storage and retrieval functionalities",
    "Quality control mechanisms",
    "Compliance with medical device standards",
    "Scalability for laboratory environments",
    "Remote diagnostics support",
    "Regular software updates",
    "Technical support services"
  ],
  "optional_modules": [
    "Advanced reporting analytics",
    "Integration with electronic health records",
    "Cloud-based data storage",
    "Automated patient notification system",
    "Multilingual support",
    "Customizable user interface themes",
    "Advanced image processing algorithms",
    "Integration with laboratory automation systems",
    "Mobile device compatibility",
    "Data visualization tools"
  ],
  "integrations": [
    "Laboratory Information Systems",
    "Electronic Health Records",
    "Laboratory Automation Systems",
    "Cloud Storage Services",
    "Mobile Devices",
    "Multilingual Support Systems",
    "Advanced Image Processing Tools",
    "Data Visualization Platforms",
    "Patient Notification Systems",
    "Remote Diagnostics Platforms"
  ],
  "data_standards": [
    "HL7 v2",
    "DICOM",
    "ICD-10",
    "SNOMED CT",
    "LOINC",
    "CPT",
    "ICD-9",
    "HL7 CDA",
    "HL7 CCD",
    "HL7 FHIR"
  ],
  "api_available": "unknown",
  "system_requirements": "Windows Server 2016 or later, Linux (Ubuntu 18.04 or later), 16 GB RAM, 500 GB HDD, 1 Gbps network connection",
  "compliance": [
    "HIPAA",
    "FDA 510(k)",
    "ISO 13485",
    "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"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "ISO 13485",
    "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",
    "Role-Based Access Control (RBAC)",
    "Single Sign-On (SSO)",
    "Audit Logs",
    "Two-Factor Authentication (2FA)",
    "Data Loss Prevention (DLP)",
    "Secure Socket Layer (SSL) Certificates",
    "Regular Security Patches",
    "User Activity Monitoring",
    "Compliance with Security Standards"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA)",
    "Consent Management",
    "Data Anonymization",
    "Data Minimization",
    "Data Masking",
    "Access Control Policies",
    "Data Retention Policies",
    "Data Encryption",
    "User Privacy Settings",
    "Compliance with Privacy Regulations"
  ],
  "data_residency": "US-only",
  "customers": [
    "Finnish Foundation for Cancer Research"
  ],
  "user_reviews": [
    "PAPNET system significantly improved detection rates compared to manual screening."
  ],
  "ratings": [
    "FDA approved in 1995 under PMA P940029."
  ],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "1995",
  "integration_partners": [
    "FDA"
  ],
  "id": "SW0650",
  "slug": "papnet-testing-system",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/papnet-testing-system.json"
  }
}