AIMC Topic: United States Food and Drug Administration

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Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning-Enabled Medical Device Recalls in the United States: Implications for Future Governance.

JMIR medical informatics Jul 11, 2025
BACKGROUND: Artificial intelligence/machine learning (AI/ML) has revolutionized the health care industry, particularly in the development and use of medical devices. The US Food and Drug Administration (FDA) has authorized over 878 AI/ML-enabled medi...
Humans United States Food and Drug Administration Device Approval Medical Device Recalls Artificial Intelligence Machine Learning United States
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The case for homebrew AI in diagnostic pathology.

The Journal of pathology Jul 4, 2025
Artificial intelligence (AI) methods for digital pathology have tremendous potential to improve cancer diagnostics, biomarkers, and ultimately patient care. These AI methods, if marketed and sold, require authorisation or clearance as in vitro diagno...
European Union Pathology, Clinical United States United States Food and Drug Administration Image Interpretation, Computer-Assisted Humans Artificial Intelligence
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Assessment of drug induced hyperuricemia and gout risk using the FDA adverse event reporting system.

Scientific reports Jul 2, 2025
Hyperuricemia, the key pathological basis of gout, is increasingly prevalent worldwide. While lifestyle factors contribute, various medications also play a role. However, their specific risks and mechanisms remain inadequately studied. Disproportiona...
Humans Female Hyperuricemia United States Food and Drug Administration Adverse Drug Reaction Reporting Systems Male Gout Middle Aged United States Risk Factors Aged Adult
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Generalizability of FDA-Approved AI-Enabled Medical Devices for Clinical Use.

JAMA network open Apr 1, 2025
IMPORTANCE: The primary objective of any newly developed medical device using artificial intelligence (AI) is to ensure its safe and effective use in broader clinical practice.
Female Cross-Sectional Studies Male Humans Artificial Intelligence Device Approval United States United States Food and Drug Administration Equipment and Supplies
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AI-Driven Analysis of Drug Marketing Efficiency: Unveiling FDA Approval to Market Release Dynamics.

The AAPS journal Feb 20, 2025
This paper explores a novel approach using generative AI to enhance drug marketing strategies in the US pharmaceutical sector. By leveraging an official dataset sourced from the US government, the AI generates Python code to analyze the time interval...
Marketing Artificial Intelligence Time Factors United States United States Food and Drug Administration Drug Industry Drug Approval Humans
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Reimbursement and Regulatory Landscape for Artificial Intelligence in Medical Technology.

Gastrointestinal endoscopy clinics of North America Jan 16, 2025
Integration of artificial intelligence (AI) into medical devices and services promises significant improvements in the diagnosis and treatment of disease. This article reviews current payment pathways for AI medical technology and the regulatory issu...
United States Food and Drug Administration Biomedical Technology Computer Security Reimbursement Mechanisms Humans Artificial Intelligence United States
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Artificial intelligence and machine learning in veterinary medicine: a regulatory perspective on current initiatives and future prospects.

American journal of veterinary research Jan 16, 2025
The US FDA's Center for Veterinary Medicine (CVM) is advancing its leadership in veterinary science by integrating AI and machine learning (ML) into its regulatory framework and scientific initiatives. This paper explores the CVM's strategic approach...
United States Food and Drug Administration Veterinary Medicine Machine Learning Animals United States Humans Artificial Intelligence
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FDA-reviewed artificial intelligence-enabled products applicable to emergency medicine.

The American journal of emergency medicine Dec 25, 2024
OBJECTIVE: To identify and assess artificial intelligence (AI)-enabled products reviewed by the U.S. Food and Drug Administration (FDA) that are potentially applicable to emergency medicine (EM).
Humans Artificial Intelligence United States United States Food and Drug Administration Emergency Medicine
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Evaluating a generative artificial intelligence accuracy in providing medication instructions from smartphone images.

Journal of the American Pharmacists Association : JAPhA Nov 6, 2024
BACKGROUND: The Food and Drug Administration mandates patient labeling materials like the Medication Guide (MG) and Instructions for Use (IFU) to support appropriate medication use. However, challenges such as low health literacy and difficulties nav...
United States Food and Drug Administration Health Literacy Pharmacists Drug Labeling Generative Artificial Intelligence United States Humans Patient Education as Topic Artificial Intelligence Smartphone
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A Machine Learning Method for Allocating Scarce COVID-19 Monoclonal Antibodies.

JAMA health forum Sep 6, 2024
IMPORTANCE: During the COVID-19 pandemic, the effective distribution of limited treatments became a crucial policy goal. Yet, limited research exists using electronic health record data and machine learning techniques, such as policy learning trees (...
Adolescent COVID-19 Female Humans Aged COVID-19 Drug Treatment Retrospective Studies Antibodies, Viral SARS-CoV-2 Machine Learning Young Adult Electronic Health Records Health Care Rationing Health Policy Hospitalization Adult Antibodies, Monoclonal Male Emergency Use Authorization Random Forest Middle Aged United States Food and Drug Administration Severity of Illness Index
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