BlueStar

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

Company Name

Welldoc

Product URL

https://www.welldoc.com/users/

Company URL

https://www.welldoc.com/

Categories

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

Summary

BlueStar is an FDA-cleared digital health platform developed by Welldoc to assist individuals in managing diabetes through personalized coaching and real-time feedback.

Description

BlueStar is a comprehensive digital health solution designed to support individuals with diabetes in self-managing their condition. It offers personalized, real-time coaching, integrates with various health devices, and facilitates communication between patients and healthcare providers. The platform has received multiple FDA clearances, including support for type 1 and type 2 diabetes, continuous glucose monitoring (CGM) integration, and insulin dosing recommendations. BlueStar is available through select organizations and is marketed in the U.S. and Canada.

Api Available

unknown

Certifications

• FDA 510(k)
• CE Mark Class IIa medical device under EU-MDR

Company Founding

2005

Company Offices

• United States
• Canada

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001

Customers

• Welldoc
• Samsung Ventures
• Merck Global Health Innovation Fund
• Adage Capital Management
• Excel Venture Management
• Alexandria Venture Investments
• Hudson River Capital Partners

Data Residency

US/EU regions

Data Standards

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

Deployment Model

• SaaS

Features

• FDA-cleared digital health solution for type 1 and type 2 diabetes management
• Insulin titration support
• Bolus calculator
• Personalized health coaching
• Integration with blood glucose monitoring and continuous glucose monitoring devices
• Continuous Glucose Monitoring (CGM) integration
• Insulin on board (IOB) feature to minimize hypoglycemia risk
• Real-time, scalable content and data
• Evidence-based care model tailored to specific chronic conditions
• Multi-condition support across pre-diabetes, diabetes, hypertension, heart failure, weight and obesity management, with integrated mental wellbeing and sleep support
• Integration with activity trackers, blood glucose meters, pharmacies, labs, and fitness trackers
• Data transfer module for insulin dosing data integration
• Compatible with connected insulin pen solutions
• Aggregates personalized data for actionable insights
• Connects with healthcare providers to optimize diabetes care
• Supports both prescription and non-prescription features
• Provides real-time, personalized coaching
• Enables sharing of progress with care teams for added support

Id

SW0536

Integration Partners

• Samsung Ventures
• Merck Global Health Innovation Fund
• Adage Capital Management
• Excel Venture Management
• Alexandria Venture Investments
• Hudson River Capital Partners

Integrations

• Dexcom G6 CGM system
• Validic's ecosystem of health devices
• Human API health data platform
• Connected insulin pen solutions
• Blood glucose meters
• Pharmacies
• Labs
• Activity and fitness trackers

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

• Advanced insulin dosing calculators
• Insulin dosing recommendations based on CGM data
• Integration with Dexcom G6 CGM system
• Integration with Validic's ecosystem of health devices
• Integration with Human API for enhanced data integration capabilities

Os Platforms

• Web
• iOS
• Android

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0536

Product Name

BlueStar

Ratings

• 3.5 out of 5 stars on G2
• 5.0 out of 5 stars on G2
• 4.9 out of 5 stars on G2
• 4.0 out of 5 stars on G2
• 4.5 out of 5 stars on G2
• 3.9 out of 5 stars on G2
• 3.8 out of 5 stars on G2
• 4.2 out of 5 stars on G2

Regions Available

• United States
• Canada

Related Urls

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

Release Year

2015

Security Features

• Encryption
• RBAC
• SSO/SAML
• Audit logs
• 2FA
• DLP

Specialties

• Diabetes Management

Support Channels

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

System Requirements

Target Users

• patients
• clinicians
• care teams

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

• Something I like about Welldoc is that you have quick access to a wide variety of topics and conditions of health and well-being.
• I love how it syncs to all devices and multiple EMR services making it seamlessly easy to manage all my data and my patients.

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "BlueStar",
  "company_name": "Welldoc",
  "product_url": "https://www.welldoc.com/users/",
  "company_url": "https://www.welldoc.com/",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0536",
  "summary": "BlueStar is an FDA-cleared digital health platform developed by Welldoc to assist individuals in managing diabetes through personalized coaching and real-time feedback.",
  "description": "BlueStar is a comprehensive digital health solution designed to support individuals with diabetes in self-managing their condition. It offers personalized, real-time coaching, integrates with various health devices, and facilitates communication between patients and healthcare providers. The platform has received multiple FDA clearances, including support for type 1 and type 2 diabetes, continuous glucose monitoring (CGM) integration, and insulin dosing recommendations. BlueStar is available through select organizations and is marketed in the U.S. and Canada.",
  "categories": [
    "clinical Care",
    "patient Facing",
    "diagnostic Support",
    "behavioral Health",
    "Clinical",
    "Patient-facing",
    "Diagnostic",
    "Behavioral Health"
  ],
  "market_segment": [
    "enterprise",
    "consumer"
  ],
  "target_users": [
    "patients",
    "clinicians",
    "care teams"
  ],
  "specialties": [
    "Diabetes Management"
  ],
  "regions_available": [
    "United States",
    "Canada"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "United States",
    "Canada"
  ],
  "company_founding": "2005",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android"
  ],
  "features": [
    "FDA-cleared digital health solution for type 1 and type 2 diabetes management",
    "Insulin titration support",
    "Bolus calculator",
    "Personalized health coaching",
    "Integration with blood glucose monitoring and continuous glucose monitoring devices",
    "Continuous Glucose Monitoring (CGM) integration",
    "Insulin on board (IOB) feature to minimize hypoglycemia risk",
    "Real-time, scalable content and data",
    "Evidence-based care model tailored to specific chronic conditions",
    "Multi-condition support across pre-diabetes, diabetes, hypertension, heart failure, weight and obesity management, with integrated mental wellbeing and sleep support",
    "Integration with activity trackers, blood glucose meters, pharmacies, labs, and fitness trackers",
    "Data transfer module for insulin dosing data integration",
    "Compatible with connected insulin pen solutions",
    "Aggregates personalized data for actionable insights",
    "Connects with healthcare providers to optimize diabetes care",
    "Supports both prescription and non-prescription features",
    "Provides real-time, personalized coaching",
    "Enables sharing of progress with care teams for added support"
  ],
  "optional_modules": [
    "Advanced insulin dosing calculators",
    "Insulin dosing recommendations based on CGM data",
    "Integration with Dexcom G6 CGM system",
    "Integration with Validic's ecosystem of health devices",
    "Integration with Human API for enhanced data integration capabilities"
  ],
  "integrations": [
    "Dexcom G6 CGM system",
    "Validic's ecosystem of health devices",
    "Human API health data platform",
    "Connected insulin pen solutions",
    "Blood glucose meters",
    "Pharmacies",
    "Labs",
    "Activity and fitness trackers"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark Class IIa medical device under EU-MDR"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [
    "Welldoc",
    "Samsung Ventures",
    "Merck Global Health Innovation Fund",
    "Adage Capital Management",
    "Excel Venture Management",
    "Alexandria Venture Investments",
    "Hudson River Capital Partners"
  ],
  "user_reviews": [
    "Something I like about Welldoc is that you have quick access to a wide variety of topics and conditions of health and well-being.",
    "I love how it syncs to all devices and multiple EMR services making it seamlessly easy to manage all my data and my patients."
  ],
  "ratings": [
    "3.5 out of 5 stars on G2",
    "5.0 out of 5 stars on G2",
    "4.9 out of 5 stars on G2",
    "4.0 out of 5 stars on G2",
    "4.5 out of 5 stars on G2",
    "3.9 out of 5 stars on G2",
    "3.8 out of 5 stars on G2",
    "4.2 out of 5 stars on G2"
  ],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "2015",
  "integration_partners": [
    "Samsung Ventures",
    "Merck Global Health Innovation Fund",
    "Adage Capital Management",
    "Excel Venture Management",
    "Alexandria Venture Investments",
    "Hudson River Capital Partners"
  ],
  "id": "SW0536",
  "slug": "bluestar",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/bluestar.json"
  }
}