Artificial intelligence in radiology: A comparative analysis of reimbursement and regulatory developments in the US and EU

This article compares emerging developments in artificial intelligence (AI) reimbursement in radiology between the United States (U.S.) and the European Union (E.U.), focusing on evolving policy proposals, regulatory frameworks, and funding disparities. While radiology accounts for over 75 % of all FDA-cleared clinical AI tools in the U.S., adoption remains limited due to multiple factors including the absence of standardized reimbursement pathways. The 2025 Health Tech Investment Act (S. 1399) bill seeks to address this by introducing a dedicated Medicare payment pathway for FDA-approved AI devices, offering transitional reimbursement for five years. In contrast, the E.U. emphasizes stringent regulation through the Medical Device Regulation (MDR) and the recently proposed AI Act but lacks a unified reimbursement strategy; adoption remains largely dependent on hospital budgets or national innovation funds. By 2025, the U.S. had authorized nearly 777 AI-enabled radiology devices, compared to approximately 200 CE-marked counterparts in Europe. U.S. investment in health AI ($11 billion in 2024) substantially surpasses Europe’s ($8 billion across all AI sectors), fueling a stronger pipeline of radiology AI startups and tools. European radiologists face financial barriers, limiting the clinical integration of AI and exacerbating workforce strain. Emerging policy directions in the in the U.S. and E.U. suggest differing approaches to radiology AI, with the U.S. pursuing proposals for reimbursement reform and the E.U. advancing regulatory oversight. Emerging global trends, particularly China’s rapid regulatory and insurance-driven AI adoption, highlight the growing importance of cross-regional policy dialogue. • U.S. and E.U. lack standardized reimbursement frameworks for AI tools in radiology. • U.S. advances CPT and NTAP routes; new bill aims to expand AI reimbursement. • E.U. leads in regulation; reimbursement remains fragmented across member states. • Global analysis shows varied AI adoption and reimbursement outside the U.S./E.U.