DeepView Wound Imaging

JSON twin: https://www.healthaidb.com/software/deepview-wound-imaging.json

Company Name

SpectralMD

Product URL

https://spectralmd.com/deepview-wound-imaging

Company URL

https://spectralmd.com

Categories

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

Summary

DeepView Wound Imaging is an AI-driven system developed by Spectral MD that provides immediate, non-invasive assessments of wound healing potential, aiding clinicians in treatment decisions for burn wounds and diabetic foot ulcers.

Description

DeepView Wound Imaging integrates proprietary AI algorithms with multispectral imaging technology to deliver rapid, accurate evaluations of wound healing potential. It assists clinicians in determining whether a wound will heal naturally or require surgical intervention, thereby improving patient outcomes and reducing healthcare costs. The system has received FDA Breakthrough Device Designation for burn wounds and is ISO 13485 certified for manufacturing and distribution. It has been deployed in various clinical settings, including burn centers and emergency departments, and has been awarded significant contracts from the U.S. government to support its development and deployment.

Api Available

unknown

Certifications

• ISO 13485
• FDA Class 1 medical device
• UKCA marking
• FDA Breakthrough Device Designation
• FDA 510(k) clearance
• CE marking
• FDA 21 CFR Part 820
• FDA 21 CFR Part 11
• FDA 21 CFR Part 820.30
• FDA 21 CFR Part 820.50
• FDA 21 CFR Part 820.60
• FDA 21 CFR Part 820.70
• FDA 21 CFR Part 820.80
• FDA 21 CFR Part 820.90
• FDA 21 CFR Part 820.100
• FDA 21 CFR Part 820.120
• FDA 21 CFR Part 820.130
• FDA 21 CFR Part 820.140
• FDA 21 CFR Part 820.150
• FDA 21 CFR Part 820.160

Company Founding

2009

Company Offices

• United States
• United Kingdom

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001
• ISO 13485
• FDA 21 CFR Part 820
• FDA 21 CFR Part 11
• FDA 21 CFR Part 820.30
• FDA 21 CFR Part 820.50
• FDA 21 CFR Part 820.60
• FDA 21 CFR Part 820.70
• FDA 21 CFR Part 820.80
• FDA 21 CFR Part 820.90
• FDA 21 CFR Part 820.100
• FDA 21 CFR Part 820.120
• FDA 21 CFR Part 820.130
• FDA 21 CFR Part 820.140
• FDA 21 CFR Part 820.150
• FDA 21 CFR Part 820.160

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
• on_prem
• hybrid

Features

• AI-driven wound healing assessment
• Multispectral imaging technology
• Non-invasive diagnostic approach
• Immediate binary output for clinicians
• Assessment of burn and diabetic foot ulcer wounds
• Integration of optical technology and AI algorithms
• Proprietary database of over 263 billion clinically validated data points
• Breakthrough Device Designation from the U.S. FDA for burn indication
• ISO 13485 certification for quality management system
• FDA Class 1 medical device classification
• UKCA marking for use in the United Kingdom
• Handheld version development for home healthcare
• Partnerships with clinical and academic institutions
• Global expansion with installations in Australia
• Non-radiation, non-laser imaging
• No injectable dye required
• Rapid image acquisition and processing
• Objective and immediate assessment of wound healing potential
• Enhanced decision-making for clinicians

Id

SW0609

Integration Partners

Integrations

• Clinical and academic institutions
• Healthcare providers
• Medical device companies
• Regulatory bodies
• Government agencies
• Hospitals
• Burn centers
• Diabetic foot ulcer clinics
• Home healthcare providers
• Research organizations
• Medical imaging systems
• Electronic health record systems
• Patient monitoring systems
• Clinical trial platforms
• Data analytics platforms
• Medical device distributors
• Healthcare technology partners
• Regulatory compliance systems
• Supply chain management systems
• Customer support platforms

Languages Supported

• English

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• Consumer

Optional Modules

• Handheld version for home healthcare

Os Platforms

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

Pricing Details

Contact vendor for pricing information.

Pricing Model

Enterprise_Quote

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization
• Data retention policies
• Data access controls
• Data sharing policies
• Data subject rights management
• Data breach notification procedures
• Data protection impact assessments

Product Code

SW0609

Product Name

DeepView Wound Imaging

Ratings

Regions Available

• United States
• United Kingdom
• 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
• Data masking
• Access controls
• Data integrity checks
• Secure data transmission

Specialties

• Burn Care
• Diabetic Foot Ulcers
• Wound Care

Support Channels

System Requirements

Non-invasive imaging device with proprietary multispectral optics and sensors

Target Users

• Clinicians
• Surgeons
• Wound Care Specialists
• Emergency Department Staff

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "DeepView Wound Imaging",
  "company_name": "SpectralMD",
  "product_url": "https://spectralmd.com/deepview-wound-imaging",
  "company_url": "https://spectralmd.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0609",
  "summary": "DeepView Wound Imaging is an AI-driven system developed by Spectral MD that provides immediate, non-invasive assessments of wound healing potential, aiding clinicians in treatment decisions for burn wounds and diabetic foot ulcers.",
  "description": "DeepView Wound Imaging integrates proprietary AI algorithms with multispectral imaging technology to deliver rapid, accurate evaluations of wound healing potential. It assists clinicians in determining whether a wound will heal naturally or require surgical intervention, thereby improving patient outcomes and reducing healthcare costs. The system has received FDA Breakthrough Device Designation for burn wounds and is ISO 13485 certified for manufacturing and distribution. It has been deployed in various clinical settings, including burn centers and emergency departments, and has been awarded significant contracts from the U.S. government to support its development and deployment.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Patient-facing"
  ],
  "market_segment": [
    "Enterprise",
    "Consumer"
  ],
  "target_users": [
    "Clinicians",
    "Surgeons",
    "Wound Care Specialists",
    "Emergency Department Staff"
  ],
  "specialties": [
    "Burn Care",
    "Diabetic Foot Ulcers",
    "Wound Care"
  ],
  "regions_available": [
    "United States",
    "United Kingdom",
    "Europe"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "Enterprise_Quote",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "United States",
    "United Kingdom"
  ],
  "company_founding": "2009",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "AI-driven wound healing assessment",
    "Multispectral imaging technology",
    "Non-invasive diagnostic approach",
    "Immediate binary output for clinicians",
    "Assessment of burn and diabetic foot ulcer wounds",
    "Integration of optical technology and AI algorithms",
    "Proprietary database of over 263 billion clinically validated data points",
    "Breakthrough Device Designation from the U.S. FDA for burn indication",
    "ISO 13485 certification for quality management system",
    "FDA Class 1 medical device classification",
    "UKCA marking for use in the United Kingdom",
    "Handheld version development for home healthcare",
    "Partnerships with clinical and academic institutions",
    "Global expansion with installations in Australia",
    "Non-radiation, non-laser imaging",
    "No injectable dye required",
    "Rapid image acquisition and processing",
    "Objective and immediate assessment of wound healing potential",
    "Enhanced decision-making for clinicians"
  ],
  "optional_modules": [
    "Handheld version for home healthcare"
  ],
  "integrations": [
    "Clinical and academic institutions",
    "Healthcare providers",
    "Medical device companies",
    "Regulatory bodies",
    "Government agencies",
    "Hospitals",
    "Burn centers",
    "Diabetic foot ulcer clinics",
    "Home healthcare providers",
    "Research organizations",
    "Medical imaging systems",
    "Electronic health record systems",
    "Patient monitoring systems",
    "Clinical trial platforms",
    "Data analytics platforms",
    "Medical device distributors",
    "Healthcare technology partners",
    "Regulatory compliance systems",
    "Supply chain management systems",
    "Customer support platforms"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10",
    "LOINC",
    "CPT",
    "ICD-9",
    "HL7 CDA",
    "HL7 CCD"
  ],
  "api_available": "unknown",
  "system_requirements": "Non-invasive imaging device with proprietary multispectral optics and sensors",
  "compliance": [
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001",
    "ISO 13485",
    "FDA 21 CFR Part 820",
    "FDA 21 CFR Part 11",
    "FDA 21 CFR Part 820.30",
    "FDA 21 CFR Part 820.50",
    "FDA 21 CFR Part 820.60",
    "FDA 21 CFR Part 820.70",
    "FDA 21 CFR Part 820.80",
    "FDA 21 CFR Part 820.90",
    "FDA 21 CFR Part 820.100",
    "FDA 21 CFR Part 820.120",
    "FDA 21 CFR Part 820.130",
    "FDA 21 CFR Part 820.140",
    "FDA 21 CFR Part 820.150",
    "FDA 21 CFR Part 820.160"
  ],
  "certifications": [
    "ISO 13485",
    "FDA Class 1 medical device",
    "UKCA marking",
    "FDA Breakthrough Device Designation",
    "FDA 510(k) clearance",
    "CE marking",
    "FDA 21 CFR Part 820",
    "FDA 21 CFR Part 11",
    "FDA 21 CFR Part 820.30",
    "FDA 21 CFR Part 820.50",
    "FDA 21 CFR Part 820.60",
    "FDA 21 CFR Part 820.70",
    "FDA 21 CFR Part 820.80",
    "FDA 21 CFR Part 820.90",
    "FDA 21 CFR Part 820.100",
    "FDA 21 CFR Part 820.120",
    "FDA 21 CFR Part 820.130",
    "FDA 21 CFR Part 820.140",
    "FDA 21 CFR Part 820.150",
    "FDA 21 CFR Part 820.160"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP",
    "Data masking",
    "Access controls",
    "Data integrity checks",
    "Secure data transmission"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization",
    "Data retention policies",
    "Data access controls",
    "Data sharing policies",
    "Data subject rights management",
    "Data breach notification procedures",
    "Data protection impact assessments"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0609",
  "slug": "deepview-wound-imaging",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/deepview-wound-imaging.json"
  }
}