FDA General

SERPINA3 and NDRG1 are critical diagnostic immune genes associated with macrophages in preeclampsia

Objective: The immune system plays a role in the occurrence and progression of numerous pregnancy complications, particularly preeclampsia (PE). This study aims to identify critical immune biomarkers via machine learning and assess their predictive ability. Methods: Gene expression data were retrieved from the GEO database, while immune-related genes were obtained from the ImmPort repository. Diff...

Comp2Comp: Open-Source Software with FDA-Cleared Artificial Intelligence Algorithms for Computed Tomography Image Analysis

Artificial intelligence allows automatic extraction of imaging biomarkers from already-acquired radiologic images. This paradigm of opportunistic imaging adds value to medical imaging without additional imaging costs or patient radiation exposure. However, many open-source image analysis solutions lack rigorous validation while commercial solutions lack transparency, leading to unexpected failures...

Early Detection of Absurdity Signals in Pharmacovigilance: A Machine Learning Ensemble Approach to Identify Rare Adverse Drug Reactions

Background: Traditional pharmacovigilance methods based on biostatistical approaches systematically exclude outliers and rare events, potentially miss...

Personalised approach to hypertension treatment: Rationale and design of the HYPERMARKER randomised trial

Background and Objective: Blood pressure treatment response is variable in individual patients, and the choice of medical therapy is often dependent o...

Explainable Deep-Learning on condition specific expression profiles reveals critical cytosines in gene regulation

Compared to other nucleotides, the cytosines stand as the most expressive one for gene regulation in plants due to its status as methylation-based epi...

Edge-Optimized Vision-Language Models for Underground Infrastructure Assessment

Autonomous inspection of underground infrastructure, such as sewer and culvert systems, is critical to public safety and urban sustainability. Althoug...

Transcriptomics-based modeling of methionine metabolism effectively estimates sample-wise DNA methylation activity and epigenetic aging

DNA methylation is a central epigenetic modification that regulates gene expression, maintains genomic stability, and guides cellular differentiation....

Reconstructing N-Glycan Profiles of Individual Glycoproteins from the Total Blood Plasma N-Glycome: Implications for Immunoglobulin G N-Glycosylation GWAS

The genetic regulation of the plasma N-glycome variation in human populations is not fully characterized, partly due to the limited sample size in gly...

An Explainable Machine Learning Approach to study the positional significance of histone post-translational modifications in gene regulation

Epigenetic mechanisms regulate gene-expression by altering the structure of the chromatin without modifying the underlying DNA sequence. Histone post-...

Graph neural network-based prediction of direct reprogramming factors using gene regulatory networks with microRNA-mediated regulation

Direct reprogramming (DR) converts somatic cells directly into target cell types while bypassing an intermediate pluripotent state, such as induced pl...

BEACON: predicting side effects and therapeutics outcomes to drugs by Bridging knowlEdge grAph with CONtextual language model

Biomedical knowledge graphs encode millions of relationships between drugs, proteins, pathways, and diseases, yet translating this structured knowledg...

Metric Hub: A metric library and practical selection workflow for use-case-driven data quality assessment in medical AI

Machine learning (ML) in medicine has transitioned from research to concrete applications aimed at supporting several medical purposes like therapy se...

Multi-omic deep learning identifies exercise-responsive ageing pathways in humans

Genome-wide association studies of physical activity traits have mapped numerous loci, yet the molecular mechanisms through which exercise influences ...

Spatial mapping of RNA turnover kinetics and regulatory landscapes of mRNA stability in the mammalian brain

Spatial and activity-dependent gene regulation in the mammalian brain requires coordinated control of RNA synthesis and degradation, yet spatially res...

InspecSafe-V1: A Multimodal Benchmark for Safety Assessment in Industrial Inspection Scenarios

With the rapid development of industrial intelligence and unmanned inspection, reliable perception and safety assessment for AI systems in complex and...

Synthetic-to-Real Domain Bridging for Single-View 3D Reconstruction of Ships for Maritime Monitoring

Three-dimensional (3D) reconstruction of ships is an important part of maritime monitoring, allowing improved visualization, inspection, and decision-...

IGF-like growth factors that couple food sensing to developmental decisions employ different release mechanisms in a single pair of C. elegans chemosensory neurons

Sensory neurons modulate organismal physiology and behavior in part by releasing neuropeptides and neurotrophins or growth factors, via the dense core...

Multi-stage Bridge Inspection System: Integrating Foundation Models with Location Anonymization

In Japan, civil infrastructure condition monitoring is mandated through visual inspection every five years. Field-captured damage images frequently co...

Technical Acquisition Parameters Dominate Demographic Factors in Chest X-ray AI Performance Disparities: A Multi-Dataset External Validation Study

Artificial intelligence systems for chest radiograph interpretation are increasingly deployed in clinical practice, yet current fairness frameworks em...

AlignInsight: A Three-Layer Framework for Detecting Deceptive Alignment and Evaluation Awareness in Healthcare AI Systems

Importance: Emerging evidence suggests healthcare AI systems may exhibit deceptive alignment (appearing safe during validation while optimizing for mi...