Minuteful 10
Comprehensive 10-parameter smartphone urinalysis testing
Company profile
Company profile
Healthy.io is a digital health company that transforms smartphone cameras into clinical-grade medical devices to deliver healthcare at the speed of life. The company's mission is to democratize access to medical care by bringing life-saving diagnostic technology to people from all walks of life, regardless of race, ethnicity, gender, religion, or location. Using colorimetric analysis, computer vision, and artificial intelligence, Healthy.io has developed a suite of FDA-cleared and CE-marked products that enable patients to perform clinical-grade tests from the comfort of their homes. The company's flagship products include Minuteful Kidney for at-home kidney disease screening, Minuteful for Wound for advanced 3D wound care assessment, Minuteful UTI for urinary tract infection testing, and Minuteful 10 for comprehensive urinalysis. These solutions address critical gaps in healthcare access, with particular focus on kidney disease—a condition affecting 35 million Americans, 90% of whom are undiagnosed. Healthy.io's technology integrates seamlessly with existing healthcare systems through SMART on FHIR compatibility and EMR integration, enabling healthcare providers, health systems, and payers to re-engage previously untested patients with up to 50% completion rates. The company serves health systems, payers, providers, and patients across three geographies, having engaged over 1.2 million patients and processed more than 1 million scans. With offices in Boston, London, and Tel Aviv, Healthy.io partners with major healthcare organizations including Blue Cross of Idaho, Medica, and Innovive Health to advance health equity and improve clinical outcomes through convenient, accessible diagnostic testing.
Company description Healthy.io Ltd official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Cloud Saas deployment with recorded integration context.
Recorded integration context: EMR systems via SMART on FHIR.
Company milestones
Partnership with Blue Cross of Idaho for early detection in rural communities. Partnership with Medica for at-risk plan patients. Partnership with Innovive Health empowering 700 wound care nurses. Named to TIME's World's Top 50 HealthTech Companies of 2025.
Partnerships
02 · Flagship portfolio
Selected source-backed Company products and the available commercial context.
Comprehensive 10-parameter smartphone urinalysis testing
Advanced 3D smartphone-based wound care assessment and monitoring
FDA-cleared smartphone-powered home kidney testing for early detection
Smartphone-powered urinary tract infection testing solution
03 · Research intelligence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Frontiers in endocrinology · Jan 1, 2023
Implementation of a patient-centered remote wound monitoring system for management of diabetic foot ulcers.Frontiers in endocrinology · Jan 1, 2023
Clinical validation
NCT04626271 · Sponsor · COMPLETED
Evaluation of the Accuracy and Usability of the Minuteful - Kidney Urine Analysis Test System in the Lay User HandsNCT05838872 · Sponsor · COMPLETED
Towards HOMe-based Albuminuria Screening: an Implementation Study Testing Two ApproachesNCT04295889 · Sponsor · UNKNOWN
Dip Home-Based Dipstick Analyzer Performance EvaluationNCT04465682 · Sponsor · COMPLETED
ACR | LAB Urine Analysis Test System Evaluation of PerformanceNCT04466501 · Sponsor · COMPLETED
A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick AnalyzerNCT04466774 · Sponsor · COMPLETED
Regulatory
K222921 · 510k · Sep 8, 2023
Minuteful - kidney testK210069 · 510k · Jul 6, 2022
ACR LAB Urine Analysis Test SystemK182384 · 510k · Jul 26, 2019
DIP/U.S. Urine Analysis Test SystemK173327 · 510k · Jul 18, 2018
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Re-engagement of previously untested patients
Overall patient satisfaction with services
Total patient engagement across platform
Total diagnostic scans processed
Partnership to help employees and Medicare Advantage patients with early kidney disease detection in rural communities
Promoting early detection in rural communities
Partnership to empower 700 wound care nurses with data-driven, high-quality wound care for vulnerable communities
700 wound care nurses empowered with Minuteful for Wound
Helping at-risk plan patients test their kidney function from home
Improved kidney health monitoring for at-risk patients
Democratizing access to care with at-home testing technology for tribal community members
Enabled patients to test in privacy of their own home
05 · Leadership
Leadership profiles and professional links from the current Company record.
06 · Company updates
Recent articles published on Healthy.io Ltd's official website.
No Company updates are currently listed.
07 · HAIC coverage
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Curated official destinations from the active Company record.
09 · Market pathway
Other active Companies in the same market, selected alphabetically from the HAIC directory.
Market context
Companies applying AI to digital pathology, histopathology slide analysis, laboratory diagnostics, or biomarker discovery. Includes AI-powered interpretation of lab test results, at-home diagnostic devices with AI analysis, and platforms that analyze tissue samples or biological specimens to support clinical diagnosis.
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Linked research, clinical, and regulatory source pathways.
Expanded product, deployment, integration, and partnership research.
Record-level provenance and review context.