Charting the Future of Radiology: Innovation, Regulation, and Real-World Impact

Radiology is accelerating into a new era where AI, digital health, and data‑centric R&D are transforming diagnostic imaging, clinical decision-making, and patient outcomes. As imaging AI scales from pilots to production, regulatory frameworks such as the EU AI Act, MDR/IVDR, and evolving FDA digital health policies are redefining how MedTech teams design, validate, and deploy AI-enabled medical devices and clinical workflows globally.

This session goes beyond awareness to deliver practical, implementation-focused insights from leaders in R&D, Regulatory Affairs, and Global Compliance who are actively shaping the next generation of intelligent radiology. Learn how your peers distinguish genuine innovation from hype, operationalize compliance for SaMD and AI/ML-enabled devices, and harness real‑world data (RWD) and post‑market evidence (RWE) to continuously improve safety, performance, and trust.

Watch this webinar to:

• Identify high‑impact radiology innovations - Learn how to separate breakthrough imaging AI and engineering advances (e.g., radiomics, workflow orchestration, clinical decision support) from noise, focusing on measurable clinical value in MRI, CT, X‑ray, ultrasound, and PET.
• Navigate complex global regulations with confidence - Understand how teams are adapting to the EU AI Act, MDR/IVDR, FDA pathways (510(k), De Novo, PMA), and standards like ISO 13485, ISO 14971, IEC 62304, IEC 62366, while aligning with HIPAA/GDPR and cybersecurity expectations.
• Leverage real‑world data for continuous improvement - See how post‑market surveillance, PMCF, and RWE feed safer, faster iteration of AI/ML models, drive label expansions, and sustain regulatory compliance.
• Accelerate development with AI & digital engineering - Explore how digital twins, simulation, cloud/edge architectures, and DICOM/HL7® FHIR® interoperability shorten cycles from concept to clinic.
• Build trust with explainability, safety, and human factors - Explore how model validation, bias mitigation, transparency, usability engineering, and robust data governance improve adoption among radiologists and care teams.
• Learn from real-world success stories - Hear how MedTech and hospital systems are scaling AI-enabled imaging solutions that improve diagnostic accuracy, reduce turnaround times, and enhance patient outcomes.