SOZO Digital Health Platform

JSON twin: https://www.healthaidb.com/software/sozo-digital-health-platform.json

Company Name

ImpediMed

Product URL

https://www.impedimed.com/products/sozo/

Company URL

https://www.impedimed.com

Categories

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

Summary

SOZO Digital Health Platform by ImpediMed is an FDA-cleared bioimpedance spectroscopy device that non-invasively assesses fluid status and tissue composition to aid in early detection and management of lymphedema and heart failure.

Description

SOZO Digital Health Platform utilizes bioimpedance spectroscopy (BIS) technology to provide clinicians with precise, non-invasive measurements of fluid status and tissue composition in less than 30 seconds. It offers applications for lymphedema assessment, body composition analysis, segmental analysis, and heart failure fluid assessment, supporting early detection and management of these conditions. The platform is FDA-cleared, CE-marked, and ARTG-listed, ensuring compliance with international medical device standards. It integrates with electronic health records (EHR) for seamless documentation and is HIPAA-compliant, ensuring secure patient data handling. The device is available in the United States, Australia, and select European countries, with support for English and other major languages. Pricing details are available upon request, and the company offers a commercial license for the software. ImpediMed was founded in 2010 and has offices in the United States, Australia, and Europe.

Api Available

yes

Certifications

• FDA 510(k)
• CE/MDR
• ONC
• ISO 27001

Company Founding

2010

Company Offices

• United States
• Australia
• Germany
• United Kingdom
• France
• Italy
• Spain
• Netherlands
• Sweden
• Norway

Compliance

• HIPAA
• HITRUST
• SOC 2
• ISO 27001
• GDPR

Customers

Data Residency

US/EU regions

Data Standards

• FHIR
• HL7 v2
• DICOM
• SNOMED
• ICD-10

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Bioimpedance spectroscopy (BIS) for lymphedema assessment
• L-Dex® score for lymphedema detection
• Body composition analysis
• Heart failure monitoring with HF-Dex™ index
• Segmental BodyComp™ analysis
• Real-time data access via MySOZO web portal
• Integration with electronic health records (EHR)
• Patient data storage in HIPAA-compliant cloud
• Encrypted data transmission and storage
• User authentication with complex passwords
• Configurable password policies
• Multi-Factor Authentication (MFA)
• Single Sign-On (SSO) support
• Detailed user logs for audit trails
• High availability and encrypted data backups
• Segregated virtual private network architecture
• Clinical Practice Guidelines support
• Lymphedema Prevention Program (LPP)
• FDA-cleared and CE-marked device
• Clinical evidence from PREVENT trial

Id

SW0532

Integration Partners

Integrations

• Epic
• Cerner
• PACS
• billing
• Active Directory
• LDAP
• Apple HealthKit
• Google Fit
• Fitbit API
• Twilio Health
• Jitsi SDK
• FHIR APIs

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Dutch
• Portuguese
• Swedish
• Norwegian
• Danish
• Finnish
• Polish
• Czech
• Hungarian
• Romanian
• Bulgarian
• Greek
• Turkish
• Russian
• Ukrainian

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb
• consumer

Optional Modules

• Hy-Dex™ hydration analysis
• Skeletal muscle mass measurement
• Fat mass measurement
• Fat-free mass measurement
• Protein and minerals analysis
• Basal metabolic rate calculation
• Phase angle measurement
• Body mass index (BMI) calculation
• Weight measurement
• Segmental outputs

Os Platforms

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

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• BAA available
• consent mgmt
• anonymization
• data minimization

Product Code

SW0532

Product Name

SOZO Digital Health Platform

Ratings

Regions Available

• United States
• Australia
• 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

Specialties

• Lymphedema
• Heart Failure
• Body Composition Analysis

Support Channels

System Requirements

Android 8.1 or greater, iOS v13 or greater, Chrome or Edge Chromium or Firefox browser

Target Users

• clinicians
• patients
• admins

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "SOZO Digital Health Platform",
  "company_name": "ImpediMed",
  "product_url": "https://www.impedimed.com/products/sozo/",
  "company_url": "https://www.impedimed.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0532",
  "summary": "SOZO Digital Health Platform by ImpediMed is an FDA-cleared bioimpedance spectroscopy device that non-invasively assesses fluid status and tissue composition to aid in early detection and management of lymphedema and heart failure.",
  "description": "SOZO Digital Health Platform utilizes bioimpedance spectroscopy (BIS) technology to provide clinicians with precise, non-invasive measurements of fluid status and tissue composition in less than 30 seconds. It offers applications for lymphedema assessment, body composition analysis, segmental analysis, and heart failure fluid assessment, supporting early detection and management of these conditions. The platform is FDA-cleared, CE-marked, and ARTG-listed, ensuring compliance with international medical device standards. It integrates with electronic health records (EHR) for seamless documentation and is HIPAA-compliant, ensuring secure patient data handling. The device is available in the United States, Australia, and select European countries, with support for English and other major languages. Pricing details are available upon request, and the company offers a commercial license for the software. ImpediMed was founded in 2010 and has offices in the United States, Australia, and Europe.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "administrative Operations",
    "Clinical",
    "Diagnostic",
    "Patient-facing",
    "Administrative"
  ],
  "market_segment": [
    "enterprise",
    "smb",
    "consumer"
  ],
  "target_users": [
    "clinicians",
    "patients",
    "admins"
  ],
  "specialties": [
    "Lymphedema",
    "Heart Failure",
    "Body Composition Analysis"
  ],
  "regions_available": [
    "United States",
    "Australia",
    "Europe"
  ],
  "languages_supported": [
    "English",
    "Spanish",
    "French",
    "German",
    "Italian",
    "Dutch",
    "Portuguese",
    "Swedish",
    "Norwegian",
    "Danish",
    "Finnish",
    "Polish",
    "Czech",
    "Hungarian",
    "Romanian",
    "Bulgarian",
    "Greek",
    "Turkish",
    "Russian",
    "Ukrainian"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States",
    "Australia",
    "Germany",
    "United Kingdom",
    "France",
    "Italy",
    "Spain",
    "Netherlands",
    "Sweden",
    "Norway"
  ],
  "company_founding": "2010",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Bioimpedance spectroscopy (BIS) for lymphedema assessment",
    "L-Dex® score for lymphedema detection",
    "Body composition analysis",
    "Heart failure monitoring with HF-Dex™ index",
    "Segmental BodyComp™ analysis",
    "Real-time data access via MySOZO web portal",
    "Integration with electronic health records (EHR)",
    "Patient data storage in HIPAA-compliant cloud",
    "Encrypted data transmission and storage",
    "User authentication with complex passwords",
    "Configurable password policies",
    "Multi-Factor Authentication (MFA)",
    "Single Sign-On (SSO) support",
    "Detailed user logs for audit trails",
    "High availability and encrypted data backups",
    "Segregated virtual private network architecture",
    "Clinical Practice Guidelines support",
    "Lymphedema Prevention Program (LPP)",
    "FDA-cleared and CE-marked device",
    "Clinical evidence from PREVENT trial"
  ],
  "optional_modules": [
    "Hy-Dex™ hydration analysis",
    "Skeletal muscle mass measurement",
    "Fat mass measurement",
    "Fat-free mass measurement",
    "Protein and minerals analysis",
    "Basal metabolic rate calculation",
    "Phase angle measurement",
    "Body mass index (BMI) calculation",
    "Weight measurement",
    "Segmental outputs"
  ],
  "integrations": [
    "Epic",
    "Cerner",
    "PACS",
    "billing",
    "Active Directory",
    "LDAP",
    "Apple HealthKit",
    "Google Fit",
    "Fitbit API",
    "Twilio Health",
    "Jitsi SDK",
    "FHIR APIs"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10"
  ],
  "api_available": "yes",
  "system_requirements": "Android 8.1 or greater, iOS v13 or greater, Chrome or Edge Chromium or Firefox browser",
  "compliance": [
    "HIPAA",
    "HITRUST",
    "SOC 2",
    "ISO 27001",
    "GDPR"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO 27001"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "audit logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "consent mgmt",
    "anonymization",
    "data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0532",
  "slug": "sozo-digital-health-platform",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/sozo-digital-health-platform.json"
  }
}