OPP002 📄 Overview A SaMD application designed for remote monitoring and self-management of Graves' Ophthalmopathy. It utilizes a smartphone's camera for periodic, AI-assisted analysis of ocular changes (e.g., proptosis, lid retraction, redness, swelling) and integrates patient-reported symptoms (double vision, eye pain, dryness, irritation). The platform provides personalized alerts for worsening conditions, educational content on GO progression, and guided self-care exercises (e.g., eye movement exercises, lubrication reminders), facilitating timely consultation with an ophthalmologist. Key technologies: 👤 Target users: 👍 Benefits Earlier detection of GO progression, potentially preventing severe complications • Empowered patients with better understanding and self-management tools for GO • Improved quality of life by managing bothersome eye symptoms • Reduced burden on specialist clinics through remote monitoring • Objective data for clinical decision-making regarding GO treatment Use bullets or new lines. 👎 Challenges Achieving sufficient diagnostic accuracy for subtle ocular changes via smartphone camera • Ensuring patient compliance with consistent photo capture and symptom logging • Regulatory clearance for an AI-driven diagnostic/monitoring tool for a specific ophthalmological condition • Managing patient anxiety related to alerts and potential misinterpretations 📋 Regulatory & Validation Likely Class II SaMD, potentially IIb depending on the level of diagnostic claim. • Requires rigorous clinical validation against ophthalmological gold standards. • Data security for sensitive biometric (facial) data is paramount. • Clear guidance on when to seek professional medical attention versus self-management.