AIMC Topic: United States Food and Drug Administration

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The first use of artificial intelligence (AI) in the ER: triage not diagnosis.

Emergency radiology Jul 8, 2020
Predictions related to the impact of AI on radiology as a profession run the gamut from AI putting radiologists out of business to having no effect at all. The use of AI appears to show significant promise in ER triage in the present. We briefly disc...
Humans Radiology Triage United States Food and Drug Administration Emergency Service, Hospital Artificial Intelligence Diagnostic Imaging United States
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Machine learning for pattern detection in cochlear implant FDA adverse event reports.

Cochlear implants international Jul 5, 2020
Medical device performance and safety databases can be analyzed for patterns and novel opportunities for improving patient safety and/or device design. The objective of this analysis was to use supervised machine learning to explore patterns in rep...
Child Humans Equipment Failure Analysis Machine Learning Cochlear Implants Logistic Models Algorithms Public Reporting of Healthcare Data Bayes Theorem Female United States Databases, Factual United States Food and Drug Administration Adult Cochlear Implantation Male
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Artificial Intelligence in Emergency Medicine: Surmountable Barriers With Revolutionary Potential.

Annals of emergency medicine Feb 21, 2020
Deep Learning Canada United States Artificial Intelligence Delivery of Health Care United States Food and Drug Administration Emergency Medicine Triage Emergency Service, Hospital Patient-Centered Care Humans Neural Networks, Computer
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Policy Implications of Artificial Intelligence and Machine Learning in Diabetes Management.

Current diabetes reports Feb 1, 2020
PURPOSE OF REVIEW: Machine learning (ML) is increasingly being studied for the screening, diagnosis, and management of diabetes and its complications. Although various models of ML have been developed, most have not led to practical solutions for rea...
Diabetes Mellitus Mass Screening Health Policy United States Food and Drug Administration Artificial Intelligence Machine Learning United States Humans
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Machine learning-based identification and rule-based normalization of adverse drug reactions in drug labels.

BMC bioinformatics Dec 23, 2019
BACKGROUND: Use of medication can cause adverse drug reactions (ADRs), unwanted or unexpected events, which are a major safety concern. Drug labels, or prescribing information or package inserts, describe ADRs. Therefore, systematically identifying A...
Drug Labeling Machine Learning Deep Learning United States Neural Networks, Computer Drug-Related Side Effects and Adverse Reactions Data Mining United States Food and Drug Administration
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The role of AI in diagnosing lung diseases.

The Lancet. Respiratory medicine Sep 26, 2019
Lung Diseases Female Humans Role United States Food and Drug Administration Male Artificial Intelligence Information Dissemination United States
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Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology.

Clinical pharmacology and therapeutics Jun 12, 2019
Generic drug products are approved by the US Food and Drug Administration (FDA) through Abbreviated New Drug Applications (ANDAs). The ANDA review and approval involves multiple offices across the FDA. Forecasting ANDA submissions can critically info...
Humans Machine Learning Time Factors Drugs, Generic Resource Allocation United States United States Food and Drug Administration Drug Approval
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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...
United States Diagnostic Imaging United States Food and Drug Administration Algorithms Patient Safety Humans Clinical Competence Artificial Intelligence
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The FDA and Artificial Intelligence in Radiology: Defining New Boundaries.

Journal of the American College of Radiology : JACR Dec 7, 2018
United States Radiology Humans United States Food and Drug Administration Artificial Intelligence
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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
United States Product Surveillance, Postmarketing United States Food and Drug Administration Humans Software Device Approval Artificial Intelligence Patient Safety
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