# iHealthScreen Wins FDA 510(k) Clearance for AI Diabetic Retinopathy Detection Software

> fda · REPORTED · 2026-07-09

iHealthScreen announced FDA 510(k) clearance (K253704) for iPredict-DR, its AI-powered Software as a Medical Device that automatically detects more than mild diabetic retinopathy in adults with diabetes not previously diagnosed with the condition, addressing a leading cause of preventable blindness.

About iHealthScreen: iHealthScreen is a healthcare AI company developing Software as a Medical Device for retinal and cardiovascular disease screening and preventive healthcare, serving providers seeking automated diagnostic support tools.

- Company: iHealthScreen
- Sector: digital health
- Primary source: https://www.businesswire.com/newsroom/industry/health/fda

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.