KidneyIntelX.dkd

JSON twin: https://www.healthaidb.com/software/kidneyintelx-dkd.json

Company Name

Renalytix

Product URL

https://renalytix.com/

Company URL

https://renalytix.com/

Categories

• diagnostic Support
• clinical Care
• administrative Operations
• Diagnostic
• Clinical
• Administrative

Summary

KidneyIntelX.dkd is an FDA-approved AI-driven prognostic test that assesses the risk of progressive kidney function decline in adults with type 2 diabetes and early-stage chronic kidney disease.

Description

KidneyIntelX.dkd combines blood-based biomarkers with clinical variables using an AI-enabled algorithm to stratify patients into low, moderate, or high-risk categories for kidney function decline over the next five years. This enables clinicians to tailor care plans and interventions more effectively, potentially improving patient outcomes and reducing healthcare costs. The test received FDA De Novo marketing authorization in June 2023 and Medicare coverage in June 2024, priced at $950 per test. Renalytix has also expanded its availability through distribution agreements in the Middle East and collaborations with healthcare institutions in the U.S.

Api Available

unknown

Certifications

• FDA 510(k)
• CE Mark
• ISO 13485
• ISO 14971
• ISO 27001
• SOC 2
• SOC 3
• CLIA
• CAP
• FDA EUA

Company Founding

2018

Company Offices

• United States
• United Kingdom
• Saudi Arabia
• Bahrain
• Qatar
• Oman
• Kuwait
• United Arab Emirates

Compliance

• HIPAA
• FDA 21 CFR Part 820
• FDA 21 CFR Part 11
• CLIA
• ISO 13485
• ISO 14971
• ISO 27001
• SOC 2
• SOC 3
• GDPR

Customers

Data Residency

US-only

Data Standards

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

Deployment Model

• SaaS

Features

• AI-enabled prognostic testing for diabetic kidney disease
• Risk stratification into low, moderate, and high categories
• Integration with electronic health records (EHR)
• Use of proprietary blood-based biomarkers (TNFR-1, TNFR-2, KIM-1)
• Clinical decision support for early intervention
• FDA-approved for assessing risk of progressive kidney function decline
• Medicare coverage with established pricing and CPT codes

Id

SW0338

Integration Partners

Integrations

• Electronic Health Records (EHR)
• Clinical Decision Support Systems (CDSS)
• Laboratory Information Management Systems (LIMS)
• Patient Portals
• Healthcare Information Exchanges (HIE)
• Clinical Practice Guidelines
• Clinical Trial Management Systems (CTMS)
• Laboratory Data Repositories
• Clinical Research Organizations (CRO)
• Healthcare Data Analytics Platforms

Languages Supported

• English
• Arabic

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

• Clinical outcomes data analysis
• Patient education programs
• Physician education programs
• Reimbursement support services
• Clinical guideline integration
• Data sharing agreements with pharmaceutical companies
• Partnerships with healthcare systems
• Clinical validation studies
• EHR data harmonization
• Clinical adjudication services

Os Platforms

• Web

Pricing Details

FDA authorized test priced at $950 per test; Medicare coverage effective August 1, 2024; contact vendor for international pricing.

Pricing Model

subscription

Privacy Features

• BAA available
• Consent Management
• Anonymization
• Data Minimization
• Data Residency
• Data Retention Policies
• Data Access Policies
• Data Sharing Agreements
• Data Breach Notification
• Data Subject Rights Management

Product Code

SW0338

Product Name

KidneyIntelX.dkd

Ratings

Regions Available

• United States
• Saudi Arabia
• Bahrain
• Qatar
• Oman
• Kuwait
• United Arab Emirates

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
• IDS/IPS
• Penetration Testing
• Data Masking
• Access Controls

Specialties

• Nephrology
• Endocrinology
• Primary Care

Support Channels

System Requirements

Target Users

• clinicians
• patients
• admins

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "KidneyIntelX.dkd",
  "company_name": "Renalytix",
  "product_url": "https://renalytix.com/",
  "company_url": "https://renalytix.com/",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0338",
  "summary": "KidneyIntelX.dkd is an FDA-approved AI-driven prognostic test that assesses the risk of progressive kidney function decline in adults with type 2 diabetes and early-stage chronic kidney disease.",
  "description": "KidneyIntelX.dkd combines blood-based biomarkers with clinical variables using an AI-enabled algorithm to stratify patients into low, moderate, or high-risk categories for kidney function decline over the next five years. This enables clinicians to tailor care plans and interventions more effectively, potentially improving patient outcomes and reducing healthcare costs. The test received FDA De Novo marketing authorization in June 2023 and Medicare coverage in June 2024, priced at $950 per test. Renalytix has also expanded its availability through distribution agreements in the Middle East and collaborations with healthcare institutions in the U.S.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "administrative Operations",
    "Diagnostic",
    "Clinical",
    "Administrative"
  ],
  "market_segment": [
    "enterprise",
    "consumer"
  ],
  "target_users": [
    "clinicians",
    "patients",
    "admins"
  ],
  "specialties": [
    "Nephrology",
    "Endocrinology",
    "Primary Care"
  ],
  "regions_available": [
    "United States",
    "Saudi Arabia",
    "Bahrain",
    "Qatar",
    "Oman",
    "Kuwait",
    "United Arab Emirates"
  ],
  "languages_supported": [
    "English",
    "Arabic"
  ],
  "pricing_model": "subscription",
  "pricing_details": "FDA authorized test priced at $950 per test; Medicare coverage effective August 1, 2024; contact vendor for international pricing.",
  "license": "commercial",
  "company_offices": [
    "United States",
    "United Kingdom",
    "Saudi Arabia",
    "Bahrain",
    "Qatar",
    "Oman",
    "Kuwait",
    "United Arab Emirates"
  ],
  "company_founding": "2018",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "AI-enabled prognostic testing for diabetic kidney disease",
    "Risk stratification into low, moderate, and high categories",
    "Integration with electronic health records (EHR)",
    "Use of proprietary blood-based biomarkers (TNFR-1, TNFR-2, KIM-1)",
    "Clinical decision support for early intervention",
    "FDA-approved for assessing risk of progressive kidney function decline",
    "Medicare coverage with established pricing and CPT codes"
  ],
  "optional_modules": [
    "Clinical outcomes data analysis",
    "Patient education programs",
    "Physician education programs",
    "Reimbursement support services",
    "Clinical guideline integration",
    "Data sharing agreements with pharmaceutical companies",
    "Partnerships with healthcare systems",
    "Clinical validation studies",
    "EHR data harmonization",
    "Clinical adjudication services"
  ],
  "integrations": [
    "Electronic Health Records (EHR)",
    "Clinical Decision Support Systems (CDSS)",
    "Laboratory Information Management Systems (LIMS)",
    "Patient Portals",
    "Healthcare Information Exchanges (HIE)",
    "Clinical Practice Guidelines",
    "Clinical Trial Management Systems (CTMS)",
    "Laboratory Data Repositories",
    "Clinical Research Organizations (CRO)",
    "Healthcare Data Analytics Platforms"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10",
    "CPT",
    "LOINC",
    "HL7 CDA",
    "HL7 CCD",
    "HL7 CCD-A"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
    "HIPAA",
    "FDA 21 CFR Part 820",
    "FDA 21 CFR Part 11",
    "CLIA",
    "ISO 13485",
    "ISO 14971",
    "ISO 27001",
    "SOC 2",
    "SOC 3",
    "GDPR"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "ISO 13485",
    "ISO 14971",
    "ISO 27001",
    "SOC 2",
    "SOC 3",
    "CLIA",
    "CAP",
    "FDA EUA"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit Logs",
    "2FA",
    "DLP",
    "IDS/IPS",
    "Penetration Testing",
    "Data Masking",
    "Access Controls"
  ],
  "privacy_features": [
    "BAA available",
    "Consent Management",
    "Anonymization",
    "Data Minimization",
    "Data Residency",
    "Data Retention Policies",
    "Data Access Policies",
    "Data Sharing Agreements",
    "Data Breach Notification",
    "Data Subject Rights Management"
  ],
  "data_residency": "US-only",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0338",
  "slug": "kidneyintelx-dkd",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/kidneyintelx-dkd.json"
  }
}