CrystarVision Co., Ltd.'s AI-based ophthalmic diagnostic support solution, Reticare (Ophthalmic Image Detection·Diagnosis Assistance Software), has been designated as an Innovative Medical Device by Korea's Ministry of Food and Drug Safety.

📋 Ministry of Food and Drug Safety Announcement No. 2026-195

• Designation Number : Integrated No. 128

• Designation Date : April 16, 2026

• Category : Advanced Technology Group

• Product Category : Ophthalmic Image Detection·Diagnosis Assistance Software

• Product Name / Model Name : Reticare / Reticare
  

The Innovative Medical Device designation program, administered by the Ministry of Food and Drug Safety, is granted to medical devices that demonstrate significantly improved safety and efficacy over existing devices through high technological intensity and the application of advanced technologies.

Reticare is an AI software that automatically analyzes a single retinal fundus photograph and simultaneously provides diagnostic labels for five major vision-threatening conditions. Unlike conventional systems limited to normal/abnormal binary classification or single-disease analysis, its key feature is Multi-disease Classification that simultaneously detects the following conditions:

• Age-related Macular Degeneration (AMD)

• Diabetic Retinopathy (DR)

• Retinal Vein Occlusion (RVO)

• Epiretinal Membrane (ERM)

• Glaucoma Suspect

This designation is a meaningful step toward CrystarVision's vision of making specialized eye care more accessible to everyone, everywhere.

CrystarVision is building more than an AI model. We are building clinical intelligence that delivers real support for ophthalmic clinical diagnosis — for the future of eye care. #MedicalDevice #OphthalmicAI #DigitalHealth #SaMD #MFDS #InnovativeMedicalDevice #Reticare #CrystarVision