FDA General

Economic evaluations of digital health interventions on maternal, newborn and child health in low-income and middle-income countries: a systematic review protocol.

INTRODUCTION: Digital health interventions have emerged as promising solutions to strengthen maternal, newborn and child health (MNCH) systems in low-income and middle-income countries (LMICs). Although evidence on their effectiveness is growing, corresponding economic evaluations remain limited, heterogeneous and fragmented. Understanding the value for money of digital health interventions is ess...

Exploring a comprehensive knowledge map for bridge management research: a Delphi-enhanced scientometric analysis.

Bridge infrastructure worldwide is aging, while demands for safety, sustainability, and cost-efficiency intensify challenges in bridge management (BM). This study develops a comprehensive knowledge map of BM through scientometric analysis, clarifying its intellectual structure, technological frontiers, and emerging themes. Using CiteSpace, 1582 peer-reviewed articles (2003-2024) from the Web of Sc...

Advances in neuropharmacology: Innovative drug strategies targeting synaptic plasticity, neuroinflammation, and ion channel regulation for future CNS treatments.

As our understanding of the molecular and cellular mechanisms underlying central nervous system (CNS) disorders expands, neuropharmacology is undergoi...

Decreasing Administrative Effort Related to Non-Approval of Image-guidED Procedures Using Large Language Models - The DENIED-AI Pilot Study.

RATIONALE AND OBJECTIVES: To evaluate whether large language models (LLMs) can generate accurate, clinically valid, and usable letters to appeal insur...

The formation mechanism and regulation of the unique flavor in fried dough products.

The distinctive aroma of fried flour-based products results from synergistic high-temperature reactions, primarily the Maillard reaction and lipid oxi...

The Role of Digital Pathology in Optimizing the Quality and Timeliness of Intraoperative Consultation.

BackgroundIntraoperative consultation using frozen sections has been crucial for guiding surgical decisions, but has often been limited by the time an...

Self-regulating the use of large language models in clinical practice: a risk-stratified approach.

The rapid integration of large language models (LLMs) into clinical practice offers promising benefits, including assistance with documentation, decis...

Analytical approaches for the isolation and characterisation of circulating tumour cells in clinical practice.

Circulating tumour cells (CTC) are rare cells shed from primary and metastatic tumours into the bloodstream, representing a minimally invasive source ...

Methodologies for mapping existent common specification, standards, and overlapping regulation for medical devices: a scoping review.

INTRODUCTION: This scoping review mapped common specifications, standards and overlapping regulations for high-risk and innovative medical devices (MD...

What FDA Clearance Does, and Does Not, Mean for Artificial Intelligence.

Probiotics: From natural to artificial.

Probiotics are live microorganisms that confer significant health benefits by maintaining gut homeostasis, regulating immune function, and producing b...

CypGEM: A Geometry-Aware and Edge-Enhanced Graph Transformer Model for Predicting Sites of Metabolism Mediated by Cytochromes P450.

Accurate prediction of a compound's site(s) of metabolism (SoMs) mediated by cytochromes P450 (CYP450) is advantageous in the early stage of drug disc...

Challenges and future directions in AI-driven biomaterials for microbiome-associated oral infectious diseases: A systematic review.

Oral biofilm-induced antimicrobial resistance is the core pathogenic mechanism of microbiome-associated oral infectious diseases (dental caries, perio...

Understanding LUng Cancer risk factors and their Impact Assessment (LUCIA): protocol for multicentre observational cohort study.

INTRODUCTION: Lung cancer (LC) is the leading cause of cancer-related mortality worldwide, primarily due to diagnosis at advanced stages. Although low...

The absence of full lifecycle risk management for AI-based medical devices in radiology.

This study represents the systematic examination of full lifecycle management for radiology artificial intelligence medical (AI) devices approved by t...

Co-morbid biomarkers for sarcopenic obesity associated with gut microbiota metabolites: From burden to treatment.

BACKGROUND: The detrimental cycle of sarcopenic obesity (SO) significantly reduces quality of life in older adults, while the mechanisms are still unc...

Auto Machine Learning for Diabetic Retinopathy Screening: A Head-to-Head Multiplatform Comparison Against Human Graders and IDx-DR.

PURPOSE: To benchmark multiple automated machine learning (AutoML) platforms for diabetic retinopathy (DR) screening from fundus photographs using a u...

Neural characteristics of emotion regulation and derived machine learning classification in high negative affectivity: Based on event-related potentials and nonlinear analysis.

As a core component of negative affectivity, high trait anxiety (HTA) elevates the risk of the onset of depressive disorders through impaired emotion ...

Imaging of Small Cell Lung Cancer: An Updated Overview of Current and Emerging Applications.

Small cell lung cancer (SCLC) is an aggressive pulmonary neuroendocrine carcinoma characterized by rapid progression and early metastasis. Despite rec...

Resilient Cooperative Optimal Output Regulation Control for Nonlinear Multiagent Systems.

This article addresses the resilient cooperative optimal output regulation (COOR) control problem for nonlinear strict-feedback multiagent systems (MA...