OPP001 📄 Overview A SaMD platform integrating continuous physiological data from wearables (e.g., heart rate variability, sleep patterns, activity, skin temperature), patient-reported symptoms (tremors, anxiety levels, heat intolerance, fatigue), and lab results (TSH, free T4, TRAb antibodies). AI algorithms analyze these multimodal inputs to provide personalized risk assessments for disease flares, optimize drug dosing suggestions, provide medication adherence reminders, and offer actionable insights to both patients and their clinicians, aiming for stable thyroid function and symptom control. Key technologies: 👤 Target users: 👍 Benefits Improved symptom control and quality of life • Reduced frequency and severity of disease flares • Optimized and personalized medication dosing • Enhanced medication adherence • Fewer urgent care visits and hospitalizations • Generation of real-world evidence for treatment efficacy Use bullets or new lines. 👎 Challenges Ensuring high accuracy and reliability of wearable data • Patient adherence to continuous use and symptom logging • Data privacy and security compliance (e.g., HIPAA, GDPR) • Integration into existing clinical workflows and EHRs • Regulatory clearance as a Class IIb SaMD 📋 Regulatory & Validation Likely Class IIb SaMD due to active monitoring and clinical decision support. • Requires extensive clinical validation for efficacy and safety. • Robust cybersecurity and data privacy measures are critical. • Clear indications for use and disclaimers regarding diagnostic/treatment recommendations.