FDA General

Expandable, But at What Cost? Failure Patterns in Corpectomy Cages From 373 Real-World Adverse Events.

STUDY DESIGN: Cross-sectional study. OBJECTIVE: This study aimed to analyze the failure patterns of expandable corpectomy cages. SUMMARY OF BACKGROUND DATA: Expandable corpectomy cages offer significant advantages for anterior column reconstruction but introduce unique mechanical complexities. Device-specific failure patterns and their clinical implications remain poorly characterized in the liter...

IQSPred-PLM: An Interpretable Quorum Sensing Peptides Prediction Model Based on Protein Language Model.

Quorum sensing regulates cooperative behaviors in bacteria through the accumulation and detection of signaling molecules. This process plays a crucial role in various biological functions, including biofilm formation, antibiotic production, regulation of virulence factors, and immune modulation. Quorum sensing peptides (QSPs), primarily produced by Gram-positive bacteria, are key components of the...

Identification of key genes in intracranial aneurysm via WGCNA: insights into immune microenvironment and therapeutic targets.

BACKGROUND: Intracranial aneurysms (IA) are prevalent vascular lesions whose rupture causes subarachnoid hemorrhage with high disability and mortality...

Advanced mass spectrometry techniques for monitoring biopharmaceutical host cell proteins.

Residual host cell proteins (HCPs) in biologic drug products can compromise safety or stability and must be carefully monitored. While traditional imm...

PRS2Net: an efficient intelligent carrot detection model via filter pruning and attention mechanisms.

BACKGROUND: Carrots, rich in essential nutrients, play a crucial role in supporting human health. Current deep learning networks for carrot quality in...

Warning: AI chatbots will soon dominate psychotherapy.

Psychotherapy chatbots have attained remarkable fluency, skill and ubiquity - having become the single most frequent reason people use artificial inte...

Surgeon, Trainee, or GPT? A Blinded Multicentric Study of AI-Augmented Operative Notes.

OBJECTIVES: Clear, complete operative documentation is essential for surgical safety, continuity of care, and medico-legal standards. Large language m...

Navigating Medical Device Safety: Current Status, Challenges, and Future Regulatory Directions.

Medical devices are indispensable in modern healthcare. They enable the prevention, diagnosis, and treatment of diseases while enhancing patient outco...

When Health Behavior Meets Technology: Artificial Neural Network-Based Prediction of Breast Self-Examination Intentions Among Filipino Female College Students.

Early detection of breast cancer is crucial, particularly in low-resource settings. Emerging technologies like artificial neural networks (ANNs) offer...

Synergistic innovation in organ-on-a-chip and organoid technologies: Reshaping the future of disease modeling, drug development and precision medicine.

FDA issued guidance on April 10th, 2025 to phase out animal trials in favor of organoids and organ-on-a-chip systems. This pivotal move was swiftly fo...

Modification and applications of glucose oxidase: optimization strategies and high-throughput screening technologies.

Glucose oxidase (GOD), an oxidoreductase (EC 1.1.3.4), catalyzes the oxidation of β-D-glucose to gluconic acid using molecular oxygen as the electron ...

Integrating Artificial Intelligence in Thyroid Nodule Management: Clinical Outcomes and Cost-Effectiveness Analysis.

OBJECTIVE: The increasing incidence of thyroid nodules (TN) raises concerns about overdiagnosis and overtreatment. This study evaluates the clinical a...

Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning-Enabled Medical Device Recalls in the United States: Implications for Future Governance.

BACKGROUND: Artificial intelligence/machine learning (AI/ML) has revolutionized the health care industry, particularly in the development and use of m...

Mapping the colon through the colonoscope's coordinates - The Copenhagen Colonoscopy Coordinate Database.

Colonoscopy is the leading endoscopic technique when it comes to implementing artificial intelligence-based tools to optimize the procedure. However, ...

Exploring graph-based models for predicting active compounds against triple-negative breast cancer.

Breast cancer is among the most dominant and rapidly rising cancers, both in India and around the world. Triple-negative breast cancer (TNBC) is one o...

FDA Draft Guidelines for AI and the Need for Ethical Frameworks.

An enhanced fusion of transfer learning models with optimization based clinical diagnosis of lung and colon cancer using biomedical imaging.

Lung and colon cancers (LCC) are among the foremost reasons for human death and disease. Early analysis of this disorder contains various tests, namel...

Air-ground collaborative multi-source orbital integrated detection system: Combining 3D imaging and intrusion recognition.

With the rapid expansion of railway networks globally, ensuring rail infrastructure safety through efficient detection methods has become critical. Tr...

The case for homebrew AI in diagnostic pathology.

Artificial intelligence (AI) methods for digital pathology have tremendous potential to improve cancer diagnostics, biomarkers, and ultimately patient...

Evolving Role of Artificial Intelligence in Endoscopic Management of Inflammatory Bowel Disease: Diagnosis, Surveillance, and Assessment.

Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, presents substantial diagnostic and management challenges because ...