AIMC Topic: United States Food and Drug Administration

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Exploring the potential of FDA approved anti-diabetic drugs for repurposing against COVID-19: a core combination of multiple computational strategies and integrated artificial intelligence.

Journal of biomolecular structure & dynamics Jul 16, 2023
The latest variant of coronavirus is omicron. The World Health Organization (WHO) designated variation 'B.1.1.529' named omicron as a variant of concern (VOC) on 26 November 2021. By September 2020, it will have infected over 16 million patients and ...
Humans Artificial Intelligence Quantitative Structure-Activity Relationship Drug Approval United States Hypoglycemic Agents Molecular Docking Simulation COVID-19 Antiviral Agents SARS-CoV-2 United States Food and Drug Administration COVID-19 Drug Treatment Drug Repositioning
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Marketing and US Food and Drug Administration Clearance of Artificial Intelligence and Machine Learning Enabled Software in and as Medical Devices: A Systematic Review.

JAMA network open Jul 3, 2023
IMPORTANCE: The marketing of health care devices enabled for use with artificial intelligence (AI) or machine learning (ML) is regulated in the US by the US Food and Drug Administration (FDA), which is responsible for approving and regulating medical...
Humans Artificial Intelligence Machine Learning United States Food and Drug Administration Device Approval Software Marketing United States
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Developing an Artificial Intelligence-Guided Signal Detection in the Food and Drug Administration Adverse Event Reporting System (FAERS): A Proof-of-Concept Study Using Galcanezumab and Simulated Data.

Drug safety Jun 10, 2023
INTRODUCTION: Time- and resource-demanding activities related to processing individual case safety reports (ICSRs) include manual procedures to evaluate individual causality with the final goal of dismissing false-positive safety signals. Eminent exp...
United States Drug-Related Side Effects and Adverse Reactions United States Food and Drug Administration Artificial Intelligence Databases, Factual Topiramate Adverse Drug Reaction Reporting Systems Amitriptyline Humans
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FDA-approved machine learning algorithms in neuroradiology: A systematic review of the current evidence for approval.

Artificial intelligence in medicine Jun 7, 2023
Over the past decade, machine learning (ML) and artificial intelligence (AI) have become increasingly prevalent in the medical field. In the United States, the Food and Drug Administration (FDA) is responsible for regulating AI algorithms as "medical...
Algorithms Databases, Factual United States Food and Drug Administration United States Artificial Intelligence Machine Learning Humans
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The regulatory environment for artificial intelligence-enabled devices in the United States.

Seminars in vascular surgery May 27, 2023
The regulatory environment in the United States has not kept pace with the rapidly developing market for artificial intelligence (AI)-enabled devices. The number of AI-enabled devices has increased year after year. All of these devices are registered...
Radiology United States Food and Drug Administration Artificial Intelligence Forecasting Humans United States
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US regulatory considerations for low field magnetic resonance imaging systems.

Magma (New York, N.Y.) May 16, 2023
Although there has been a resurgence of interest in low field magnetic resonance imaging (MRI) systems in recent years, low field MRI is not a new concept. FDA has a long history of evaluating the safety and effectiveness of MRI systems encompassing ...
United States Food and Drug Administration United States Magnetic Resonance Imaging Artificial Intelligence
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Bayesian Statistics for Medical Devices: Progress Since 2010.

Therapeutic innovation & regulatory science Mar 3, 2023
The use of Bayesian statistics to support regulatory evaluation of medical devices began in the late 1990s. We review the literature, focusing on recent developments of Bayesian methods, including hierarchical modeling of studies and subgroups, borro...
Research Design Child Sample Size Bayes Theorem United States Humans United States Food and Drug Administration Artificial Intelligence
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Trends in clinical validation and usage of US Food and Drug Administration-cleared artificial intelligence algorithms for medical imaging.

Clinical radiology Oct 28, 2022
AIM: To examine the current landscape of US Food and Drug Administration (FDA)-approved artificial intelligence (AI) medical imaging devices and identify trends in clinical validation strategy.
Diagnostic Imaging United States Food and Drug Administration Humans Retrospective Studies Algorithms Artificial Intelligence United States
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The current status and future of FDA-approved artificial intelligence tools in chest radiology in the United States.

Clinical radiology Sep 28, 2022
Artificial intelligence (AI) is becoming more widespread within radiology. Capabilities that AI algorithms currently provide include detection, segmentation, classification, and quantification of pathological findings. Artificial intelligence softwar...
Radiology Humans United States Food and Drug Administration Artificial Intelligence Radiography, Thoracic Algorithms United States
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Utilizing Deep Learning for Detecting Adverse Drug Events in Structured and Unstructured Regulatory Drug Data Sets.

Pharmaceutical medicine Jul 24, 2022
BACKGROUND: The US Food and Drug Administration (FDA) collects and retains several data sets on post-market drugs and associated adverse events (AEs). The FDA Adverse Event Reporting System (FAERS) contains millions of AE reports submitted by the pub...
Drug-Related Side Effects and Adverse Reactions United States Food and Drug Administration Adverse Drug Reaction Reporting Systems United States Humans Pharmaceutical Preparations Deep Learning
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