AIMC Topic: Equipment and Supplies

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Development of an explainable machine learning model for predicting device-related pressure injuries in clinical settings.

BMC medical informatics and decision making Jul 9, 2025
BACKGROUND: Device-related pressure injury (DRPI) is a prevalent and severe problem for patients using medical devices. Timely identification of patients at high risk of DRPI is crucial for healthcare providers to make informed decisions and prevent ...
Pressure Ulcer Aged Adult Middle Aged Equipment and Supplies Male Machine Learning Female Humans
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[Regulatory classification of AI-enabled products for medical use on the basis of the EU AI Act and MDR/IVDR].

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Jul 4, 2025
The use of artificial intelligence (AI) in healthcare offers great potential but also presents regulatory challenges. The EU Artificial Intelligence Act (AIA), the Medical Device Regulation (MDR), and the Regulation on in vitro diagnostic medical dev...
Artificial Intelligence Europe Equipment and Supplies Humans Equipment Safety European Union Medical Device Legislation Germany Device Approval
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A Machine Learning-Based Clustering Analysis to Explore Bisphenol A and Phthalate Exposure from Medical Devices in Infants with Congenital Heart Defects.

Environmental health perspectives Jun 18, 2025
BACKGROUND: Plastic-containing medical devices are commonly used in critical care units and other patient care settings. Patients are often exposed to xenobiotic agents that are leached out from plastic-containing medical devices, including bisphenol...
Cluster Analysis Phenols Environmental Pollutants Male Infant Benzhydryl Compounds Phthalic Acids Heart Defects, Congenital Environmental Exposure Equipment and Supplies Humans Female Infant, Newborn Machine Learning Bisphenol A Compounds
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Generalizability of FDA-Approved AI-Enabled Medical Devices for Clinical Use.

JAMA network open Apr 1, 2025
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.
Device Approval United States Food and Drug Administration Equipment and Supplies Male Humans United States Female Cross-Sectional Studies Artificial Intelligence
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A decision-making framework for evaluating medical equipment suppliers under uncertainty.

Scientific reports Mar 21, 2025
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...
Decision Making Equipment and Supplies Uncertainty Decision Support Techniques Fuzzy Logic Humans
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Embracing a Penta helix hub framework for co-creating sustaining and potentially disruptive sterilization innovation that enables artificial intelligence and sustainability: A scoping review.

The Science of the total environment Mar 14, 2025
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...
Artificial Intelligence Equipment and Supplies Inventions Sterilization
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Risk-based evaluation of machine learning-based classification methods used for medical devices.

BMC medical informatics and decision making Mar 11, 2025
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...
Equipment and Supplies Humans Machine Learning Risk Assessment
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Exploration of the optimal deep learning model for english-Japanese machine translation of medical device adverse event terminology.

BMC medical informatics and decision making Feb 8, 2025
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 ...
Translating Equipment and Supplies Terminology as Topic Translations Deep Learning Japan
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Regulatory approaches towards AI Medical Devices: A comparative study of the United States, the European Union and China.

Health policy (Amsterdam, Netherlands) Feb 1, 2025
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...
Government Regulation European Union Medical Device Legislation Equipment and Supplies Device Approval Humans China United States Artificial Intelligence
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The translation of in-house imaging AI research into a medical device ensuring ethical and regulatory integrity.

European journal of radiology Nov 26, 2024
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...
Equipment and Supplies Diagnostic Imaging Humans Translational Research, Biomedical Artificial Intelligence
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