OPP001 📄 Overview A SaMD platform that integrates data from patient EHRs, wearables, imaging studies, and lab results to continuously monitor patients undergoing regenerative therapies. It tracks functional outcomes, detects early signs of adverse events, and generates comprehensive real-world evidence (RWE) to support long-term safety and efficacy claims for novel treatments. Key technologies: 👤 Target users: 👍 Benefits Accelerates RWE generation for novel therapies • Enhances patient safety through early detection of complications • Supports value-based care models • Informs personalized treatment adjustments • Facilitates post-market surveillance Use bullets or new lines. 👎 Challenges Data standardization and interoperability across diverse sources • Regulatory approval and validation as a SaMD • Cybersecurity and data privacy compliance • User adoption and integration into clinical workflows 📋 Regulatory & Validation Likely Class IIb or III SaMD, depending on specific claims (e.g., diagnostic interpretation vs. pure monitoring). • Requires robust clinical validation studies to demonstrate accuracy and clinical utility. • Compliance with ISO 13485 for quality management system.