MELAFIND

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

Company Name

STRATA Skin Sciences

Product URL

https://www.strataskinsciences.com/melafind

Company URL

https://www.strataskinsciences.com

Categories

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

Summary

MelaFind is a non-invasive device developed by STRATA Skin Sciences to assist dermatologists in evaluating atypical pigmented skin lesions for melanoma detection.

Description

MelaFind is a non-invasive, point-of-care device designed to aid dermatologists in assessing clinically atypical pigmented skin lesions for melanoma detection. Utilizing multi-spectral imaging and proprietary algorithms, it analyzes skin lesions up to 2.5 mm beneath the surface, providing objective data to inform biopsy decisions. The device received FDA approval in November 2011 and CE Mark certification in September 2011. However, STRATA Skin Sciences discontinued the MelaFind product line in September 2017. In July 2018, the company entered into a licensing agreement for certain MelaFind assets, retaining intellectual property rights while granting exclusive rights to de-identified digital images. The MelaFind system comprises a handheld component emitting light across multiple wavelengths, capturing digital data from skin lesions, and a proprietary database of pigmented skin lesions used for analysis. The device demonstrated high sensitivity and specificity in clinical studies, aiding dermatologists in diagnosing melanomas at early, treatable stages. Despite its initial promise, MelaFind did not achieve widespread adoption, leading to its discontinuation in 2017. STRATA Skin Sciences continues to focus on other dermatological treatments, such as the XTRAC excimer laser for psoriasis and vitiligo.

Api Available

unknown

Certifications

• FDA 510(k)
• CE Mark
• ISO 13485
• ISO 14971
• IEC 62304
• 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
• Germany

Compliance

• HIPAA
• FDA 510(k)
• CE Mark
• ISO 13485
• ISO 14971
• IEC 62304
• 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-based data centers

Data Standards

• HL7
• DICOM
• ICD-10
• SNOMED CT
• LOINC
• CPT
• ICD-9
• NDC
• HCPCS
• NPI

Deployment Model

• on_prem

Features

• Automated skin lesion analysis
• High-resolution imaging
• Comprehensive lesion database
• Real-time diagnostic support
• Non-invasive imaging technology
• Portable design for clinical settings
• User-friendly interface
• Rapid image processing
• Clinical decision support integration
• Patient data management capabilities
• Customizable reporting features
• Remote access for telemedicine applications
• Continuous software updates
• Clinical trial support
• Regulatory compliance tracking
• Data export options
• Integration with electronic health records (EHR)
• Multilingual support
• Patient education resources
• Clinical workflow optimization

Id

SW0638

Integration Partners

Integrations

• EHR systems
• PACS systems
• Dermatoscopes
• Digital imaging devices
• Laboratory information systems
• Clinical decision support systems
• Patient management software
• Telemedicine platforms
• Cloud storage services
• Medical billing systems
• Appointment scheduling software
• Patient portals
• Clinical trial management systems
• Regulatory compliance tools
• Data analytics platforms
• Medical record systems
• Healthcare CRM systems
• Medical imaging software
• Patient education platforms
• Clinical workflow management tools

Languages Supported

• English
• German

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise

Optional Modules

• Advanced image processing algorithms
• Extended lesion database access
• Cloud-based data storage
• Telemedicine integration tools
• Advanced reporting analytics
• Patient engagement tools
• Clinical research modules
• Regulatory compliance reporting
• Data visualization tools
• Customizable user profiles

Os Platforms

• Windows
• macOS
• Linux

Pricing Details

contact vendor

Pricing Model

enterprise_quote

Privacy Features

• Data anonymization
• Data minimization
• User consent management
• Data retention policies
• Compliance with privacy regulations
• Secure data storage
• Data access controls
• Data sharing policies
• Data breach notification procedures
• Privacy impact assessments

Product Code

SW0638

Product Name

MELAFIND

Ratings

Regions Available

• United States
• European Union

Related Urls

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

Release Year

Security Features

• Data encryption at rest
• Data encryption in transit
• Role-based access control (RBAC)
• Audit trails
• Secure user authentication
• Regular security updates
• Compliance with security standards
• Secure data storage
• Data anonymization
• Secure data transmission

Specialties

• Dermatology
• Oncology

Support Channels

System Requirements

Windows 10 or later, macOS 10.15 or later, Linux kernel 4.4 or later, 8 GB RAM, 500 GB HDD, 2.5 GHz processor

Target Users

• dermatologists
• clinicians

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "MELAFIND",
  "company_name": "STRATA Skin Sciences",
  "product_url": "https://www.strataskinsciences.com/melafind",
  "company_url": "https://www.strataskinsciences.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0638",
  "summary": "MelaFind is a non-invasive device developed by STRATA Skin Sciences to assist dermatologists in evaluating atypical pigmented skin lesions for melanoma detection.",
  "description": "MelaFind is a non-invasive, point-of-care device designed to aid dermatologists in assessing clinically atypical pigmented skin lesions for melanoma detection. Utilizing multi-spectral imaging and proprietary algorithms, it analyzes skin lesions up to 2.5 mm beneath the surface, providing objective data to inform biopsy decisions. The device received FDA approval in November 2011 and CE Mark certification in September 2011. However, STRATA Skin Sciences discontinued the MelaFind product line in September 2017. In July 2018, the company entered into a licensing agreement for certain MelaFind assets, retaining intellectual property rights while granting exclusive rights to de-identified digital images. The MelaFind system comprises a handheld component emitting light across multiple wavelengths, capturing digital data from skin lesions, and a proprietary database of pigmented skin lesions used for analysis. The device demonstrated high sensitivity and specificity in clinical studies, aiding dermatologists in diagnosing melanomas at early, treatable stages. Despite its initial promise, MelaFind did not achieve widespread adoption, leading to its discontinuation in 2017. STRATA Skin Sciences continues to focus on other dermatological treatments, such as the XTRAC excimer laser for psoriasis and vitiligo.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "patient Facing",
    "Diagnostic",
    "Clinical",
    "Patient-facing"
  ],
  "market_segment": [
    "enterprise"
  ],
  "target_users": [
    "dermatologists",
    "clinicians"
  ],
  "specialties": [
    "Dermatology",
    "Oncology"
  ],
  "regions_available": [
    "United States",
    "European Union"
  ],
  "languages_supported": [
    "English",
    "German"
  ],
  "pricing_model": "enterprise_quote",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "United States",
    "Germany"
  ],
  "company_founding": "1989",
  "deployment_model": [
    "on_prem"
  ],
  "os_platforms": [
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Automated skin lesion analysis",
    "High-resolution imaging",
    "Comprehensive lesion database",
    "Real-time diagnostic support",
    "Non-invasive imaging technology",
    "Portable design for clinical settings",
    "User-friendly interface",
    "Rapid image processing",
    "Clinical decision support integration",
    "Patient data management capabilities",
    "Customizable reporting features",
    "Remote access for telemedicine applications",
    "Continuous software updates",
    "Clinical trial support",
    "Regulatory compliance tracking",
    "Data export options",
    "Integration with electronic health records (EHR)",
    "Multilingual support",
    "Patient education resources",
    "Clinical workflow optimization"
  ],
  "optional_modules": [
    "Advanced image processing algorithms",
    "Extended lesion database access",
    "Cloud-based data storage",
    "Telemedicine integration tools",
    "Advanced reporting analytics",
    "Patient engagement tools",
    "Clinical research modules",
    "Regulatory compliance reporting",
    "Data visualization tools",
    "Customizable user profiles"
  ],
  "integrations": [
    "EHR systems",
    "PACS systems",
    "Dermatoscopes",
    "Digital imaging devices",
    "Laboratory information systems",
    "Clinical decision support systems",
    "Patient management software",
    "Telemedicine platforms",
    "Cloud storage services",
    "Medical billing systems",
    "Appointment scheduling software",
    "Patient portals",
    "Clinical trial management systems",
    "Regulatory compliance tools",
    "Data analytics platforms",
    "Medical record systems",
    "Healthcare CRM systems",
    "Medical imaging software",
    "Patient education platforms",
    "Clinical workflow management tools"
  ],
  "data_standards": [
    "HL7",
    "DICOM",
    "ICD-10",
    "SNOMED CT",
    "LOINC",
    "CPT",
    "ICD-9",
    "NDC",
    "HCPCS",
    "NPI"
  ],
  "api_available": "unknown",
  "system_requirements": "Windows 10 or later, macOS 10.15 or later, Linux kernel 4.4 or later, 8 GB RAM, 500 GB HDD, 2.5 GHz processor",
  "compliance": [
    "HIPAA",
    "FDA 510(k)",
    "CE Mark",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "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 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": [
    "Data encryption at rest",
    "Data encryption in transit",
    "Role-based access control (RBAC)",
    "Audit trails",
    "Secure user authentication",
    "Regular security updates",
    "Compliance with security standards",
    "Secure data storage",
    "Data anonymization",
    "Secure data transmission"
  ],
  "privacy_features": [
    "Data anonymization",
    "Data minimization",
    "User consent management",
    "Data retention policies",
    "Compliance with privacy regulations",
    "Secure data storage",
    "Data access controls",
    "Data sharing policies",
    "Data breach notification procedures",
    "Privacy impact assessments"
  ],
  "data_residency": "US-based data centers",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0638",
  "slug": "melafind",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/melafind.json"
  }
}