We examine the transformative potential of artificial intelligence (AI) in medical imaging diagnosis, focusing on improving diagnostic accuracy and efficiency through advanced algorithms. It addresses the significant challenges preventing immediate clinical adoption of AI, specifically from technical, ethical, and legal perspectives. The aim is to highlight the current state of AI in medical imaging and outline the necessary steps to ensure safe, effective, and ethically sound clinical implementation. We conduct a comprehensive discussion, with special emphasis on the technical requirements for robust AI models, the ethical frameworks needed for responsible deployment, and the legal implications, including data privacy and regulatory compliance. Explainable artificial intelligence (XAI) is examined as a means to increase transparency and build trust among healthcare professionals and patients. The analysis reveals key challenges to AI integration in clinical settings, including the need for extensive high-quality datasets, model reliability, advanced infrastructure, and compliance with regulatory standards. The lack of explainability in AI outputs remains a barrier, with XAI identified as crucial for meeting transparency standards and enhancing trust among end users. Overcoming these barriers requires a collaborative, multidisciplinary approach to integrate AI into clinical practice responsibly. Addressing technical, ethical, and legal issues will support a softer transition, fostering a more accurate, efficient, and patient-centered healthcare system where AI augments traditional medical practices.

The increasing integration of Artificial Intelligence (AI) into health and biomedical systems necessitates robust frameworks for transparency, accountability, and ethical compliance. Existing frameworks often rely on human-readable, manual documentation which limits scalability, comparability, and machine interpretability across projects and platforms. They also fail to provide a unique, verifiable identity for AI models to ensure their provenance and authenticity across systems and use cases, limiting reproducibility and stakeholder trust. This paper introduces the concept of the AI Model Passport, a structured and standardized documentation framework that acts as a digital identity and verification tool for AI models. It captures essential metadata to uniquely identify, verify, trace and monitor AI models across their lifecycle - from data acquisition and preprocessing to model design, development and deployment. In addition, an implementation of this framework is presented through AIPassport, an MLOps tool developed within the ProCAncer-I EU project for medical imaging applications. AIPassport automates metadata collection, ensures proper versioning, decouples results from source scripts, and integrates with various development environments. Its effectiveness is showcased through a lesion segmentation use case using data from the ProCAncer-I dataset, illustrating how the AI Model Passport enhances transparency, reproducibility, and regulatory readiness while reducing manual effort. This approach aims to set a new standard for fostering trust and accountability in AI-driven healthcare solutions, aspiring to serve as the basis for developing transparent and regulation compliant AI systems across domains.

Radiology has evolved from the pioneering days of X-ray imaging to a field rich in advanced technologies on the cusp of a transformative future driven by artificial intelligence (AI). As imaging workloads grow in volume and complexity, and economic as well as environmental pressures intensify, visionary leadership is needed to navigate the unprecedented challenges and opportunities ahead. Leveraging its strengths in automation, accuracy and objectivity, AI will profoundly impact all aspects of radiology practice-from workflow management, to imaging, diagnostics, reporting and data-driven analytics-freeing radiologists to focus on value-driven tasks that improve patient care. However, successful AI integration requires strong leadership and robust governance structures to oversee algorithm evaluation, deployment, and ongoing maintenance, steering the transition from static to continuous learning systems. The vision of a "diagnostic cockpit" that integrates multidimensional data for quantitative precision diagnoses depends on visionary leadership that fosters innovation and interdisciplinary collaboration. Through administrative automation, precision medicine, and predictive analytics, AI can enhance operational efficiency, reduce administrative burden, and optimize resource allocation, leading to substantial cost reductions. Leaders need to understand not only the technical aspects but also the complex human, administrative, and organizational challenges of AI's implementation. Establishing sound governance and organizational frameworks will be essential to ensure ethical compliance and appropriate oversight of AI algorithms. As radiology advances toward this AI-driven future, leaders must cultivate an environment where technology enhances rather than replaces human skills, upholding an unwavering commitment to human-centered care. Their vision will define radiology's pioneering role in AI-enabled healthcare transformation. KEY POINTS: Question Artificial intelligence (AI) will transform radiology, improving workflow efficiency, reducing administrative burden, and optimizing resource allocation to meet imaging workloads' increasing complexity and volume. Findings Strong leadership and governance ensure ethical deployment of AI, steering the transition from static to continuous learning systems while fostering interdisciplinary innovation and collaboration. Clinical relevance Visionary leaders must harness AI to enhance, rather than replace, the role of professionals in radiology, advancing human-centered care while pioneering healthcare transformation.

Coronary CT Angiography (CCTA) is essential for assessing atherosclerosis and coronary artery disease, aiding in early detection, risk prediction, and clinical assessment. However, traditional CCTA interpretation is limited by observer variability, time inefficiency, and inconsistent plaque characterization. AI has emerged as a transformative tool, enhancing diagnostic accuracy, workflow efficiency, and risk prediction for major adverse cardiovascular events (MACE). Studies show that AI improves stenosis detection by 27%, inter-reader agreement by 30%, and reduces reporting times by 40%, thereby addressing key limitations of manual interpretation. Integrating AI with multimodal imaging (e.g., FFR-CT, PET-CT) further enhances ischemia detection by 28% and lesion classification by 35%, providing a more comprehensive cardiovascular evaluation. This review synthesizes recent advancements in CCTA-AI automation, risk stratification, and precision diagnostics while critically analyzing data quality, generalizability, ethics, and regulation challenges. Future directions, including real-time AI-assisted triage, cloud-based diagnostics, and AI-driven personalized medicine, are explored for their potential to revolutionize clinical workflows and optimize patient outcomes.

Artificial intelligence (AI) algorithms and deep learning continue to change the landscape of radiology. New algorithms promise to enhance diagnostic accuracy, improve workflow efficiency, and automate repetitive tasks. This article provides a narrative review of the FDA-cleared AI algorithms which are commercially available in the United States as of late 2024 and targeted toward assessment of abdominopelvic organs and related diseases, evaluates potential advantages of using AI, and suggests future directions for the field.

The objective of this study is to map the global scientific competitive landscape in the field of artificial intelligence (AI) medical devices using scientific data. A bibliometric analysis was conducted using the Web of Science Core Collection to examine global research trends in AI-based medical devices. As of the end of 2023, a total of 55 147 relevant publications were identified worldwide, with 76.6% published between 2018 and 2024. Research in this field has primarily focused on AI-assisted medical image and physiological signal analysis. At the national level, China (17 991 publications) and the United States (14 032 publications) lead in output. China has shown a rapid increase in publication volume, with its 2023 output exceeding twice that of the U.S.; however, the U.S. maintains a higher average citation per paper (China: 16.29; U.S.: 35.99). At the institutional level, seven Chinese institutions and three U.S. institutions rank among the global top ten in terms of publication volume. At the researcher level, prominent contributors include Acharya U Rajendra, Rueckert Daniel and Tian Jie, who have extensively explored AI-assisted medical imaging. Some researchers have specialized in specific imaging applications, such as Yang Xiaofeng (AI-assisted precision radiotherapy for tumors) and Shen Dinggang (brain imaging analysis). Others, including Gao Xiaorong and Ming Dong, focus on AI-assisted physiological signal analysis. The results confirm the rapid global development of AI in the medical device field, with "AI + imaging" emerging as the most mature direction. China and the U.S. maintain absolute leadership in this area-China slightly leads in publication volume, while the U.S., having started earlier, demonstrates higher research quality. Both countries host a large number of active research teams in this domain.

As artificial intelligence (AI) becomes increasingly prevalent within interventional radiology (IR) research and clinical practice, steps must be taken to ensure the robustness of novel technological systems presented in peer-reviewed journals. This report introduces comprehensive standards and an evaluation checklist (iCARE) that covers the application of modern AI methods in IR-specific contexts. The iCARE checklist encompasses the full "code-to-clinic" pipeline of AI development, including dataset curation, pre-training, task-specific training, explainability, privacy protection, bias mitigation, reproducibility, and model deployment. The iCARE checklist aims to support the development of safe, generalizable technologies for enhancing IR workflows, the delivery of care, and patient outcomes.

Clinical decision-making is inherently complex, time-sensitive, and prone to error. AI-enabled clinical decision support systems (CDSS) offer promising solutions by leveraging large datasets to provide evidence-based recommendations. These systems range from rule-based and knowledge-based to increasingly AI-driven approaches. However, key challenges persist, particularly concerning data quality, seamless integration into clinical workflows, and clinician trust and acceptance. Ethical and legal considerations, especially data privacy, are also paramount.AI-CDSS have demonstrated success in fields like radiology (e.g., pulmonary nodule detection, mammography interpretation) and cardiology, where they enhance diagnostic accuracy and improve patient outcomes. Looking ahead, chat and voice interfaces powered by large language models (LLMs) could support shared decision-making (SDM) by fostering better patient engagement and understanding.To fully realize the potential of AI-CDSS in advancing efficient, patient-centered care, it is essential to ensure their responsible development. This includes grounding AI models in domain-specific data, anonymizing user inputs, and implementing rigorous validation of AI-generated outputs before presentation. Thoughtful design and ethical oversight will be critical to integrating AI safely and effectively into clinical practice.

The emergence of new-generation artificial intelligence technology has brought numerous innovations to the healthcare field, including telemedicine and intelligent care. However, the artificial intelligent medical device sector still faces significant challenges, such as data privacy protection and algorithm reliability. This study, based on invention patent analysis, revealed the technological innovation trends in the field of artificial intelligent medical devices from aspects such as patent application time trends, hot topics, regional distribution, and innovation players. The results showed that global invention patent applications had remained active, with technological innovations primarily focused on medical image processing, physiological signal processing, surgical robots, brain-computer interfaces, and intelligent physiological parameter monitoring technologies. The United States and China led the world in the number of invention patent applications. Major international medical device giants, such as Philips, Siemens, General Electric, and Medtronic, were at the forefront of global technological innovation, with significant advantages in patent application volumes and international market presence. Chinese universities and research institutes, such as Zhejiang University, Tianjin University, and the Shenzhen Institute of Advanced Technology, had demonstrated notable technological innovation, with a relatively high number of patent applications. However, their overseas market expansion remained limited. This study provides a comprehensive overview of the technological innovation trends in the artificial intelligent medical device field and offers valuable information support for industry development from an informatics perspective.

Artificial intelligence (AI) is a disruptive technology that is currently finding widespread application after having long been confined to the domain of specialists. In urology, in particular, new fields of application are continuously emerging, which are being studied both in preclinical basic research and in clinical applications. Potential applications include image recognition in the operating room or interpreting images from radiology and pathology, the automatic measurement of urinary stones and radiotherapy. Certain medical devices, particularly in the field of AI-based predictive biomarkers, have already been incorporated into international guidelines. In addition, AI is playing an increasingly more important role in administrative tasks and is expected to lead to enormous changes, especially in the outpatient sector. For urologists, it is becoming increasingly more important to engage with this technology, to pursue appropriate training and therefore to optimally implement AI into the treatment of patients and in the management of their practices or hospitals.