AIMC Topic: United States Food and Drug Administration
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Concepts in U.S. Food and Drug Administration Regulation of Artificial Intelligence for Medical Imaging.
AJR. American journal of roentgenology
Jun 5, 2019
Although extensive attention has been focused on the enormous potential of artificial intelligence (AI) technology, a major question remains: how should this fundamentally new technology be regulated? The purpose of this article is to provide an ove...
The FDA and Artificial Intelligence in Radiology: Defining New Boundaries.
Journal of the American College of Radiology : JACR
Dec 7, 2018
The Role of the FDA in Ensuring the Safety and Efficacy of Artificial Intelligence Software and Devices.
Journal of the American College of Radiology : JACR
Oct 30, 2018
Evaluation of Natural Language Processing (NLP) systems to annotate drug product labeling with MedDRA terminology.
Journal of biomedical informatics
Jun 1, 2018
INTRODUCTION: The FDA Adverse Event Reporting System (FAERS) is a primary data source for identifying unlabeled adverse events (AEs) in a drug or biologic drug product's postmarketing phase. Many AE reports must be reviewed by drug safety experts to ...
Development of Decision Forest Models for Prediction of Drug-Induced Liver Injury in Humans Using A Large Set of FDA-approved Drugs.
Scientific reports
Dec 11, 2017
Drug-induced liver injury (DILI) presents a significant challenge to drug development and regulatory science. The FDA's Liver Toxicity Knowledge Base (LTKB) evaluated >1000 drugs for their likelihood of causing DILI in humans, of which >700 drugs wer...
Development of A Machine Learning Algorithm to Classify Drugs Of Unknown Fetal Effect.
Scientific reports
Oct 9, 2017
Many drugs commonly prescribed during pregnancy lack a fetal safety recommendation - called FDA 'category C' drugs. This study aims to classify these drugs into harmful and safe categories using knowledge gained from chemoinformatics (i.e., pharmacol...
Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data.
PloS one
Apr 20, 2016
BACKGROUND: Use of robotic systems for minimally invasive surgery has rapidly increased during the last decade. Understanding the causes of adverse events and their impact on patients in robot-assisted surgery will help improve systems and operationa...
Edoxaban vs warfarin in patients with nonvalvular atrial fibrillation in the US Food and Drug Administration approval population: An analysis from the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) trial.
American heart journal
Dec 1, 2015
BACKGROUND: Edoxaban is a specific anti-Xa inhibitor that, in comparison to warfarin, has been found to be noninferior for the prevention of stroke or systemic embolism (SSE) and to reduce bleeding significantly in patients with nonvalvular atrial fi...
United States Food and Drug Administration
Thiazoles
Factor Xa
Pyridines
Male
Thrombolytic Therapy
Stroke
United States
Humans
Anticoagulants
Myocardial Infarction
Blood Coagulation
Dose-Response Relationship, Drug
Atrial Fibrillation
Female
Double-Blind Method
Factor Xa Inhibitors
Aged
Warfarin
Drug Approval
Role of AI in Clinical Decision-Making: An Analysis of FDA Medical Device Approvals.
Studies in health technology and informatics
Aug 7, 2025
The U.S. Food and Drug Administration (FDA) plays an important role in ensuring safety and effectiveness of AI/ML-enabled devices through its regulatory processes. In recent years, there has been an increase in the number of these devices cleared by ...
Drug repurposing to identify potential FDA-approved drugs targeting three main angiogenesis receptors through a deep learning framework.
Molecular diversity
Aug 1, 2025
Tumor cell survival depends on the presence of oxygen and nutrients provided by existing blood vessels, particularly when cancer is in its early stage. Along with tumor growth in the vicinity of blood vessels, malignant cells require more nutrients; ...
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