AIMC Topic: United States Food and Drug Administration

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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 Pharmaceutical Preparations Machine Learning Protein Kinases United States United States Food and Drug Administration Protein Kinase Inhibitors
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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...
Technology Republic of Korea United States United States Food and Drug Administration Humans 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...
Artificial Intelligence Machine Learning Research Design Drug Discovery Humans United States Food and Drug Administration Digital Technology Drug Industry Biomedical Technology Health Information Exchange Clinical Trials as Topic Health Care Sector United States Drug Development Remote Sensing Technology Virtual Reality Time Factors Mobile Applications
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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.
Artificial Intelligence Machine Learning Algorithms ROC Curve Humans United States United States Food and Drug Administration
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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
Kinetics United States Food and Drug Administration Algorithms United States 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...
Gynecologic Surgical Procedures Laparoscopy Robotic Surgical Procedures United States Food and Drug Administration Humans Equipment Failure Robotics 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-...
Machine Learning United States United States Food and Drug Administration Humans 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 Machine Learning Feedback United States Medical Informatics United States Food and Drug Administration Software Government Regulation Equipment and Supplies Algorithms Delivery of Health Care
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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...
Candida albicans Cyclopropanes Drug Repositioning Molecular Dynamics Simulation Sulfonamides Candidiasis Antifungal Agents Tetrahydrofolate Dehydrogenase Molecular Docking Simulation Benzodioxoles Deep Learning Drug Approval United States Rifampin United States Food and Drug Administration Humans Folic Acid Antagonists Proline Aminopyridines Lactams, Macrocyclic
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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...
Diagnostic Test Approval Risk Assessment Skin Neoplasms Smartphone Europe Precancerous Conditions United States Humans Mobile Applications Adult United States Food and Drug Administration Evidence-Based Medicine Early Detection of Cancer Artificial Intelligence Sensitivity and Specificity European Union Algorithms
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