AIMC Topic: United States Food and Drug Administration

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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...
Humans Artificial Intelligence Databases, Factual United States United States Food and Drug Administration Machine Learning Algorithms
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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...
Humans Forecasting Artificial Intelligence United States Radiology United States Food and Drug Administration
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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 United States Humans Artificial Intelligence United States Food and Drug Administration Sample Size Bayes Theorem
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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.
United States Diagnostic Imaging United States Food and Drug Administration Algorithms Retrospective Studies Humans Artificial Intelligence
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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 United States Food and Drug Administration Algorithms Radiography, Thoracic Humans United States Artificial Intelligence
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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...
United States Pharmaceutical Preparations United States Food and Drug Administration Adverse Drug Reaction Reporting Systems Drug-Related Side Effects and Adverse Reactions Humans Deep Learning
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Discovery of moiety preference by Shapley value in protein kinase family using random forest models.

BMC bioinformatics Apr 15, 2022
BACKGROUND: Human protein kinases play important roles in cancers, are highly co-regulated by kinase families rather than a single kinase, and complementarily regulate signaling pathways. Even though there are > 100,000 protein kinase inhibitors, onl...
Humans United States Pharmaceutical Preparations Machine Learning Protein Kinases Protein Kinase Inhibitors United States Food and Drug Administration
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The current status of breakthrough devices designation in the United States and innovative medical devices designation in Korea for digital health software.

Expert review of medical devices Mar 23, 2022
INTRODUCTION: Artificial Intelligence (AI) is becoming increasingly utilized in the medical device industry as it can address unmet demands in clinical sites and provide more patient treatment options. This study aims to analyze the FDA's Breakthroug...
United States Food and Drug Administration Technology Republic of Korea Humans United States Artificial Intelligence Software
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Advancing pharmacy and healthcare with virtual digital technologies.

Advanced drug delivery reviews Jan 5, 2022
Digitalisation of the healthcare sector promises to revolutionise patient healthcare globally. From the different technologies, virtual tools including artificial intelligence, blockchain, virtual, and augmented reality, to name but a few, are provid...
United States Food and Drug Administration Digital Technology Drug Discovery Drug Industry Biomedical Technology Machine Learning Drug Development Humans Virtual Reality Research Design Health Information Exchange Clinical Trials as Topic Mobile Applications Remote Sensing Technology Artificial Intelligence Time Factors Health Care Sector United States
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