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...
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...
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...
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...
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...
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.
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...
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-...
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