FDA General

Biologics for severe asthma: deciphering what is best for the patient.

INTRODUCTION: Choosing the right biologic for the right patient is challenging. It requires evaluati...

Walking Backward to Ensure Risk Management of Large Language Models in Medicine.

This paper examines in what way providers of specialized Large Language Models (LLM) pre-trained and...

Clinical efficacy of AI in lung SABR planning: A comparative retrospective analysis.

This study evaluated the effectiveness of an integrated Artificial Intelligence (AI) planning tool i...

Development of an anomaly detection system for Gibbs artifact identification in amyloid PET imaging.

The PET Imaging Site Qualification Program for amyloid positron emission tomography (PET) in Japan i...

Evaluating a brief smartphone-based stress management intervention with heart rate biofeedback from built-in sensors in a three arm randomized controlled trial.

Perceived stress is prevalent in industrial societies, negatively impacting mental health. Smartphon...

Genome-wide annotation and comparative analysis of miniature inverted-repeat transposable elements (MITEs) in six pear species.

Through multi-faceted comparative analysis of MITEs across six pear genomes, we revealed their distr...

Analysis of the neural mechanisms of social anxiety based on EEG features and machine learning and construction of a diagnostic model.

Social anxiety is a common psychological problem, and its accurate diagnosis and investigation of un...

The Future of Automated Insulin Delivery Systems.

Automated insulin delivery (AID) systems have revolutionized diabetes care by integrating continuous...

Psychedelics, entactogens and psychoplastogens for depression and related disorders.

Currently, the most actively investigated rapidly acting antidepressants, anxiolytics and/or anti PT...

From neurotoxicity to neuroprotection: Rethinking GABAR-targeting anesthetics.

The brain growth spurt (BGS) represents a pivotal window in neurodevelopment, defined by rapid neuro...

Semantic Search of FDA Guidance Documents Using Generative AI.

INTRODUCTION: Generative artificial intelligence (AI) has the potential to transform and accelerate ...

An Artificial Intelligence Solution for Automated Dental Inspection and Charting.

BACKGROUND: Visual inspection and documentation (charting) of findings are critical components in de...

2D van der Waals heterostructure memristors: from band structure regulation to neuromorphic computing applications.

Two-dimensional (2D) materials and their van der Waals heterostructures (vdWHs) have shown tremendou...

Advancements and Applications of Hyperpolarized Xenon MRI for COPD Assessment in China.

Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and mortality...

SCATrans: semantic cross-attention transformer for drug-drug interaction predication through multimodal biomedical data.

Predicting potential drug-drug interactions (DDIs) from biomedical data plays a critical role in dru...

Single-cell sequencing and machine learning reveal the role of dioxin-interacting genes in HCC prognosis and immune microenvironment.

Dioxins are persistent environmental pollutants that bioaccumulate in the food chain, posing signifi...

Machine Learning Based Quantitative Structure-Dissolution Profile Relationship.

Determining accurate drug dissolution processes in the gastrointestinal tract is critical in drug di...

The illusion of safety: A report to the FDA on AI healthcare product approvals.

Artificial intelligence is rapidly transforming healthcare, offering promising advancements in diagn...

Identifying dynamic regulation with machine learning using adversarial surrogates.

Biological systems maintain stability of their function in spite of external and internal perturbati...

Letter Regarding "Overview of South Korean Guidelines for Approval of Large Language or Multimodal Models as Medical Devices: Key Features and Areas for Improvement".

Ethical Considerations for Generative Artificial Intelligence in Plastic Surgery.

The integration of artificial intelligence (AI) into surgical care is rapidly transforming healthcar...