TED_002 📄 Overview A prescription digital therapeutic designed to deliver personalized interventions for TED symptoms such as diplopia, dry eye, and psychosocial distress. It could include guided eye exercises (e.g., ocular motility, fusion exercises), mindfulness modules for anxiety, and cognitive behavioral therapy (CBT) techniques adapted for chronic illness management. Integrates with symptom tracking and provides progress reports to clinicians. Key technologies: 👤 Target users: 👍 Benefits Improved visual function and reduced diplopia • Better management of dry eye symptoms and discomfort • Enhanced coping mechanisms for anxiety and body image issues • Increased patient self-efficacy and adherence to prescribed therapies • Reduced healthcare utilization for symptom flares Use bullets or new lines. 👎 Challenges Demonstrating clinical efficacy through rigorous trials • Ensuring long-term patient engagement and adherence • Establishing clear reimbursement pathways as a DTx • Personalizing content for the wide range of TED presentations 📋 Regulatory & Validation Likely Class I or Class II SaMD, depending on specific claims and risk profile (e.g., general wellness vs. specific therapeutic intervention). • Requires FDA clearance (or equivalent) as a medical device.