AIMC Topic: United States Food and Drug Administration
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Navigating FDA Regulations for the Development of Artificial Intelligence Technologies in Plastic Surgery.
Aesthetic surgery journal
Jul 15, 2025
Artificial intelligence (AI) technologies are rapidly transforming the field of plastic surgery, offering new opportunities for improving patient outcomes through enhanced diagnostic capabilities, personalized treatment planning, and outcome predicti...
BoostDILI: Extreme Gradient Boost-Powered Drug-Induced Liver Injury Prediction and Structural Alerts Generation.
Chemical research in toxicology
May 19, 2025
Over the past 60 years, drug-induced liver injury (DILI) has played a key role in the withdrawal of marketed drugs due to safety concerns. Early prediction of DILI is crucial for developing safer pharmaceuticals, yet current and testing methods are...
Repurposing FDA-approved drugs as NLRP3 inhibitors against inflammatory diseases: machine learning and molecular simulation approaches.
Journal of biomolecular structure & dynamics
May 1, 2025
Activation of NLRP3 (NOD-like receptor family, pyrin domain-containing protein 3) has been associated with multiple chronic pathologies, including diabetes, atherosclerosis, and rheumatoid arthritis. Moreover, histone deacetylases (HDACs), specifical...
FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine.
JAMA
Jan 21, 2025
IMPORTANCE: Advances in artificial intelligence (AI) must be matched by efforts to better understand and evaluate how AI performs across health care and biomedicine as well as develop appropriate regulatory frameworks. This Special Communication revi...
A Machine Learning Algorithm to Predict Medical Device Recall by the Food and Drug Administration.
The western journal of emergency medicine
Jan 1, 2025
INTRODUCTION: Medical device recalls are important to the practice of emergency medicine, as unsafe devices include many ubiquitous items in emergency care, such as vascular access devices, ventilators, infusion pumps, video laryngoscopes, pulse oxim...
Implications of An Evolving Regulatory Landscape on the Development of AI and ML in Medicine.
Pacific Symposium on Biocomputing. Pacific Symposium on Biocomputing
Jan 1, 2025
The rapid advancement of artificial intelligence and machine learning (AI/ML) technologies in healthcare presents significant opportunities for enhancing patient care through innovative diagnostic tools, monitoring systems, and personalized treatment...
Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety.
Journal of the American Medical Informatics Association : JAMIA
Jun 20, 2024
OBJECTIVES: Surface the urgent dilemma that healthcare delivery organizations (HDOs) face navigating the US Food and Drug Administration (FDA) final guidance on the use of clinical decision support (CDS) software.
Characterisation of digital therapeutic clinical trials: a systematic review with natural language processing.
The Lancet. Digital health
Mar 1, 2024
Digital therapeutics (DTx) are a somewhat novel class of US Food and Drug Administration-regulated software that help patients prevent, manage, or treat disease. Here, we use natural language processing to characterise registered DTx clinical trials ...
FDA Review of Radiologic AI Algorithms: Process and Challenges.
Radiology
Jan 1, 2024
A Food and Drug Administration (FDA)-cleared artificial intelligence (AI) algorithm misdiagnosed a finding as an intracranial hemorrhage in a patient, who was finally diagnosed with an ischemic stroke. This scenario highlights a notable failure mode ...
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