Precision medicine and data
Roche Kidney Klinrisk Algorithm
AI-powered CKD progression risk algorithm that uses standard demographic and lab parameters to produce kidney-function decline risk scores and clinical decision support.
Last updated: June 7, 2026
Back to directoryHealthy.io Minuteful Kidney medical AI product profile
Home kidney-testing service that uses a smartphone app, test kit, colorimetric analysis, computer vision, and AI to measure urine albumin, creatinine, and ACR.
Precision medicine and data
Best fit
Payers and care teams trying to close kidney health testing gaps for people with diabetes, hypertension, or other CKD risk factors without requiring a lab visit.
- Primary use case
- FDA-cleared smartphone-powered home urine albumin-to-creatinine ratio testing with AI and computer-vision analysis
- Audience
- Health plans, primary care groups, kidney-care programs, population health teams, and at-risk patients offered home kidney testing
- Risk level
- High
- Pricing signal
- Often offered through health plans or care programs; verify current eligibility, prescription, coverage, kit, outreach, and telehealth terms.
- Official sources
- 5 official sources
Compare within workflow: Precision medicine and data · comparison shortlist · source index
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Healthy.io Minuteful Kidney as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as a regulated in vitro diagnostic home-use workflow; match the exact app, kit, analytes, prescription pathway, FDA 510(k), state availability, and intended use before deployment. |
|---|---|
| Privacy | Review app account data, health-plan or provider sharing, telehealth partners, support access, retention, state availability, consent, and whether the contracting party needs a BAA or data-processing agreement. |
| Evidence | Verify FDA decision materials, clinical-grade claims, adherence data, ACR measurement performance, abnormal-result follow-up, and whether local users can complete testing with supported phones. |
| Workflow | Best governed as a population-health testing and follow-up workflow where results are shared with clinicians, abnormal findings trigger outreach, and patients are told the test is not a standalone diagnosis. |
Where Healthy.io Minuteful Kidney fits
Healthy.io and Minuteful materials describe Minuteful Kidney as a smartphone-powered home urine ACR test that uses colorimetric analysis, computer vision, and AI; public terms and FDA materials describe prescription-use home testing, 510(k) clearance, albumin and creatinine measurement, and clinician review boundaries.
Not for: Autonomous kidney diagnosis, emergency assessment, treatment changes without clinician review, or use outside prescription, state, payer, and FDA-cleared workflow limits.
What to verify before using Healthy.io Minuteful Kidney
- Whether the patient population, state, health-plan arrangement, prescription workflow, and smartphone requirements match the current Minuteful Kidney terms.
- FDA 510(k), intended use, analytes, prescription-only status, app and kit version, telehealth handoff, and clinician follow-up responsibilities.
- How urine results, app data, identity, eligibility, telehealth information, support access, retention, and health-plan sharing are handled.
- Local adherence, repeat testing, abnormal-result escalation, primary-care follow-up, equity, device access, and downstream CKD care outcomes.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- minuteful.com
- healthy.io / services / kidney
- blog.healthy.io / company-news / minuteful-kidney-receives-fda-clearance
- minuteful.com / us / kidney
- www.accessdata.fda.gov / cdrh_docs / pdf22
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