Technology and health care : official journal of the European Society for Engineering and Medicine
40105179
BackgroundHealthcare institutions throughout the world rely on medical devices to provide their services reliably and effectively. However, medical devices can, and do sometimes fail. These failures pose significant risk to patients.ObjectiveOne way ...
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation
39638633
Intelligent medical devices are flourishing with the deep integration of modern information and artificial intelligence technologies into healthcare. Testing is an important means of performance evaluation and quality control for intelligent medical ...
This manuscript delineates the pathway from in-house research on Artificial Intelligence (AI) to the development of a medical device, addressing critical phases including conceptualization, development, validation, and regulatory compliance. Key stag...
The swift progression of AI within the realm of medical devices has precipitated an imperative for stringent regulatory oversight. The United States, the European Union, and China stand as vanguard entities in the regulatory landscape for AI-enhanced...
BMC medical informatics and decision making
39923074
BACKGROUND: In Japan, reporting of medical device malfunctions and related health problems is mandatory, and efforts are being made to standardize terminology through the Adverse Event Terminology Collection of the Japan Federation of Medical Device ...
The procurement of medical equipment is a critical concern for healthcare organizations striving to deliver comprehensive patient care. Thus, the procurement process, including performance evaluation and selection of medical equipment suppliers, pose...
The supply of safe pipeline medical devices is of paramount importance. Opportunities exist to transform reusable medical devices for improved processing that meets diverse patient needs. There is increased interest in multi-actor hub frameworks to m...
BMC medical informatics and decision making
40069689
BACKGROUND: In the future, more medical devices will be based on machine learning (ML) methods. In general, the consideration of risks is a crucial aspect for evaluating medical devices. Accordingly, risks and their associated costs should be taken i...
IMPORTANCE: The primary objective of any newly developed medical device using artificial intelligence (AI) is to ensure its safe and effective use in broader clinical practice.
Studies in health technology and informatics
40200442
Artificial Intelligence (AI) is increasingly incorporated into medical devices, revolutionizing diagnostics, treatment planning, and patient monitoring. To ensure AI's safe and ethical use, the European Commission published the AI Act in 2024, which ...