AIMC Topic: United States Food and Drug Administration

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FDA-regulated AI Algorithms: Trends, Strengths, and Gaps of Validation Studies.

Academic radiology Dec 27, 2021
RATIONALE AND OBJECTIVES: To assess key trends, strengths, and gaps in validation studies of the Food and Drug Administration (FDA)-regulated imaging-based artificial intelligence/machine learning (AI/ML) algorithms.
Algorithms ROC Curve United States United States Food and Drug Administration Humans Artificial Intelligence Machine Learning
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What's Needed to Bridge the Gap Between US FDA Clearance and Real-world Use of AI Algorithms.

Academic radiology Nov 20, 2021
Algorithms United States Kinetics United States Food and Drug Administration Humans Artificial Intelligence
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Malfunction Events in the US FDA MAUDE Database: How Does Robotic Gynecologic Surgery Compare with Other Specialties?

Journal of minimally invasive gynecology Aug 28, 2021
STUDY OBJECTIVE: To review malfunction events (MEs) related to the use of the da Vinci robot reported to the United States Food and Drug Administration Manufacturer and User Facility Device Experience in the last 10 years and compare gynecologic surg...
Robotic Surgical Procedures United States Food and Drug Administration Gynecologic Surgical Procedures Equipment Failure Robotics Laparoscopy Humans Female United States
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The role of machine learning in clinical research: transforming the future of evidence generation.

Trials Aug 16, 2021
BACKGROUND: Interest in the application of machine learning (ML) to the design, conduct, and analysis of clinical trials has grown, but the evidence base for such applications has not been surveyed. This manuscript reviews the proceedings of a multi-...
United States Food and Drug Administration Machine Learning Humans United States Artificial Intelligence
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Continual learning in medical devices: FDA's action plan and beyond.

The Lancet. Digital health Apr 28, 2021
Humans Equipment and Supplies Algorithms Medical Informatics Delivery of Health Care Government Regulation Feedback Machine Learning United States Software United States Food and Drug Administration
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Deep-learning based repurposing of FDA-approved drugs against dihydrofolate reductase and molecular dynamics study.

Journal of biomolecular structure & dynamics Apr 21, 2021
causes the fatal fungal bloodstream infection in humans called Candidiasis. Most of the species are resistant to the antifungals used to treat them. Drug-resistant poses very serious public health issues. To overcome this, the development of effec...
Sulfonamides United States Food and Drug Administration Proline Candidiasis Antifungal Agents Molecular Dynamics Simulation Folic Acid Antagonists Aminopyridines Tetrahydrofolate Dehydrogenase Benzodioxoles Lactams, Macrocyclic Drug Approval Rifampin Humans Molecular Docking Simulation Deep Learning Cyclopropanes Drug Repositioning United States Candida albicans
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AI-based smartphone apps for risk assessment of skin cancer need more evaluation and better regulation.

British journal of cancer Mar 19, 2021
Smartphone applications ("apps") with artificial intelligence (AI) algorithms are increasingly used in healthcare. Widespread adoption of these apps must be supported by a robust evidence-base and app manufacturers' claims appropriately regulated. Cu...
Algorithms Skin Neoplasms Adult Smartphone European Union United States Food and Drug Administration Mobile Applications Humans Diagnostic Test Approval Precancerous Conditions Sensitivity and Specificity Artificial Intelligence United States Evidence-Based Medicine Risk Assessment Early Detection of Cancer Europe
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Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015-20): a comparative analysis.

The Lancet. Digital health Jan 18, 2021
There has been a surge of interest in artificial intelligence and machine learning (AI/ML)-based medical devices. However, it is poorly understood how and which AI/ML-based medical devices have been approved in the USA and Europe. We searched governm...
Humans Government Regulation United States Artificial Intelligence Equipment and Supplies Radiology Europe Machine Learning Device Approval United States Food and Drug Administration Databases, Factual Biomedical Technology
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Applications of artificial intelligence in drug development using real-world data.

Drug discovery today Dec 24, 2020
The US Food and Drug Administration (FDA) has been actively promoting the use of real-world data (RWD) in drug development. RWD can generate important real-world evidence reflecting the real-world clinical environment where the treatments are used. M...
Machine Learning Drug Repositioning Animals United States Food and Drug Administration Deep Learning Humans United States Artificial Intelligence Drug Development
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Industry ties and evidence in public comments on the FDA framework for modifications to artificial intelligence/machine learning-based medical devices: a cross sectional study.

BMJ open Oct 14, 2020
OBJECTIVES: To determine the extent and disclosure of financial ties to industry and use of scientific evidence in comments on a US Food and Drug Administration (FDA) regulatory framework for modifications to artificial intelligence/machine learning ...
United States Food and Drug Administration Machine Learning Humans Drug Industry Artificial Intelligence Cross-Sectional Studies Conflict of Interest Disclosure United States
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