Minuteful Kidney

JSON twin: https://www.healthaidb.com/software/minuteful-kidney.json

Company Name

Healthy.io

Product URL

https://healthy.io/minuteful-kidney

Company URL

https://healthy.io

Categories

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

Summary

Minuteful Kidney is a smartphone-powered, FDA-cleared at-home test that enables users to detect early signs of chronic kidney disease (CKD) by measuring urine albumin-to-creatinine ratio (ACR) through a simple urine test, providing instant clinical-grade results without the need for lab visits.

Description

Minuteful Kidney is a home-based testing solution developed by Healthy.io, designed to facilitate early detection of chronic kidney disease (CKD). Utilizing a smartphone camera, the test measures the urine albumin-to-creatinine ratio (ACR), a key indicator of kidney function. The process involves receiving a test kit at home, conducting the test via a user-friendly app, and obtaining immediate results that can be shared with healthcare providers for timely intervention. This approach aims to increase testing adherence among at-risk populations and improve health outcomes by enabling early diagnosis and management of CKD.

Api Available

unknown

Certifications

• FDA 510(k) clearance
• CE mark

Company Founding

2013

Company Offices

• United States
• United Kingdom
• Israel

Compliance

• HIPAA
• ISO 27001
• GDPR
• FDA 21 CFR Part 820
• EN ISO 13486:2016
• EU Medical Device Directive 93/42/EEC

Customers

Data Residency

US and EU regions

Data Standards

• HL7
• FHIR

Deployment Model

• SaaS

Features

• FDA-cleared smartphone-powered home kidney test
• Instant clinical-grade results
• Guided testing via smartphone app
• Compatible with a wide range of iOS and Android devices
• No need for lab visits or sample mailing
• Secure sharing of results with healthcare providers
• Supports early detection of chronic kidney disease (CKD)
• Increases testing adherence among at-risk populations

Id

SW0319

Integration Partners

Integrations

• Electronic Medical Records (EMRs)

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Hebrew

Last Updated

2025-10-11

License

Commercial

Market Segment

• Consumer
• Enterprise

Optional Modules

Os Platforms

• iOS
• Android

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• HIPAA compliance
• GDPR compliance
• ISO 27001 certification

Product Code

SW0319

Product Name

Minuteful Kidney

Ratings

Regions Available

• United States
• United Kingdom
• Europe
• Israel

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 and in transit (AES-256, TLS 1.2)
• Secure cloud hosting (Google Cloud Platform)
• Regular disaster recovery exercises
• Incident response plan
• Single Sign-On (SSO) support (Auth0 2.0, SAML, ADFS, SMART on FHIR)

Specialties

• Nephrology
• Primary Care
• Preventive Medicine

Support Channels

System Requirements

iOS 13.0+, Android 8.0+, 3 GB RAM, 64-bit processor, 720x1280 display, Gyroscope

Target Users

• Patients
• Clinicians
• Healthcare Providers
• Health Plans

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Minuteful Kidney",
  "company_name": "Healthy.io",
  "product_url": "https://healthy.io/minuteful-kidney",
  "company_url": "https://healthy.io",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0319",
  "summary": "Minuteful Kidney is a smartphone-powered, FDA-cleared at-home test that enables users to detect early signs of chronic kidney disease (CKD) by measuring urine albumin-to-creatinine ratio (ACR) through a simple urine test, providing instant clinical-grade results without the need for lab visits.",
  "description": "Minuteful Kidney is a home-based testing solution developed by Healthy.io, designed to facilitate early detection of chronic kidney disease (CKD). Utilizing a smartphone camera, the test measures the urine albumin-to-creatinine ratio (ACR), a key indicator of kidney function. The process involves receiving a test kit at home, conducting the test via a user-friendly app, and obtaining immediate results that can be shared with healthcare providers for timely intervention. This approach aims to increase testing adherence among at-risk populations and improve health outcomes by enabling early diagnosis and management of CKD.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "mobile Health",
    "Clinical",
    "Diagnostic",
    "Patient-facing",
    "Mobile Health"
  ],
  "market_segment": [
    "Consumer",
    "Enterprise"
  ],
  "target_users": [
    "Patients",
    "Clinicians",
    "Healthcare Providers",
    "Health Plans"
  ],
  "specialties": [
    "Nephrology",
    "Primary Care",
    "Preventive Medicine"
  ],
  "regions_available": [
    "United States",
    "United Kingdom",
    "Europe",
    "Israel"
  ],
  "languages_supported": [
    "English",
    "Spanish",
    "French",
    "German",
    "Italian",
    "Hebrew"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "United States",
    "United Kingdom",
    "Israel"
  ],
  "company_founding": "2013",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "iOS",
    "Android"
  ],
  "features": [
    "FDA-cleared smartphone-powered home kidney test",
    "Instant clinical-grade results",
    "Guided testing via smartphone app",
    "Compatible with a wide range of iOS and Android devices",
    "No need for lab visits or sample mailing",
    "Secure sharing of results with healthcare providers",
    "Supports early detection of chronic kidney disease (CKD)",
    "Increases testing adherence among at-risk populations"
  ],
  "optional_modules": [],
  "integrations": [
    "Electronic Medical Records (EMRs)"
  ],
  "data_standards": [
    "HL7",
    "FHIR"
  ],
  "api_available": "unknown",
  "system_requirements": "iOS 13.0+, Android 8.0+, 3 GB RAM, 64-bit processor, 720x1280 display, Gyroscope",
  "compliance": [
    "HIPAA",
    "ISO 27001",
    "GDPR",
    "FDA 21 CFR Part 820",
    "EN ISO 13486:2016",
    "EU Medical Device Directive 93/42/EEC"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "CE mark"
  ],
  "security_features": [
    "Data encryption at rest and in transit (AES-256, TLS 1.2)",
    "Secure cloud hosting (Google Cloud Platform)",
    "Regular disaster recovery exercises",
    "Incident response plan",
    "Single Sign-On (SSO) support (Auth0 2.0, SAML, ADFS, SMART on FHIR)"
  ],
  "privacy_features": [
    "HIPAA compliance",
    "GDPR compliance",
    "ISO 27001 certification"
  ],
  "data_residency": "US and EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0319",
  "slug": "minuteful-kidney",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/minuteful-kidney.json"
  }
}