TED_001 📄 Overview A SaMD platform integrating patient-reported outcomes (PROMs) via a mobile app, alongside AI analysis of patient-submitted eye images (e.g., selfies, guided image capture for proptosis/lid lag) and potentially eye-tracking data. The system would monitor subtle changes, score disease activity (e.g., CAS), and alert clinicians to potential flares or progression, enabling proactive intervention. Key technologies: 👤 Target users: 👍 Benefits Earlier detection of disease flares • Reduced need for in-person clinic visits • Improved patient peace of mind and self-management • Objective, longitudinal disease activity tracking • Personalized treatment adjustments Use bullets or new lines. 👎 Challenges Ensuring consistent image capture quality by patients • Validation of AI algorithms across diverse populations and disease stages • Maintaining patient engagement for continuous monitoring • Regulatory clearance for diagnostic/monitoring claims • Integration with existing EHR systems 📋 Regulatory & Validation Likely Class II SaMD for monitoring and diagnostic support. • Requires robust clinical validation studies to demonstrate accuracy and clinical utility. • Data privacy (HIPAA, GDPR) and security are paramount.