FDA General

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...

Prediction of air temperature and humidity in greenhouses via artificial neural network.

Accurate prediction of greenhouse temperature and relative humidity is critical for developing envir...

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...

Feature and classifier-level domain adaptation in DistilHuBERT for cross-corpus speech emotion recognition.

Cross-corpus speech emotion recognition (CCSER) aims to develop robust models capable of accurately ...

Sleep Identification Enabled by Supervised Training Algorithms (SIESTA): An Open-Source Platform for Automatic Sleep Staging of Rodent Electrocorticographic and Electromyographic Data.

Accurately capturing the temporal distribution of polysomnographic sleep stages is critical for the ...

Inconsistency of AI in intracranial aneurysm detection with varying dose and image reconstruction.

Scanner-related changes in data quality are common in medical imaging, yet monitoring their impact o...

"Calming the nightmares": A qualitative study of a socially assistive robot for sensory and emotional support in individuals with eating disorders and PTSD.

Individuals with eating disorders (ED) and co-occurring post-traumatic stress disorder (PTSD) often ...

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".

DFT_ANPD: A dual-feature two-sided attention network for anticancer natural products detection.

The exploration of anticancer drugs has aimed at more effective, adaptable, and less harmful treatme...

Context-Aware Biosensor Design Through Biology-Guided Machine Learning and Dynamical Modeling.

Addressing the challenge of achieving a global circular bioeconomy requires efficient and robust bio...

Double-edged sword? Heterogeneous effects of digital technology on environmental regulation-driven green transformation.

In the context of China's dual carbon goal, enterprises' green transformation is a key path to advan...

Ethical Considerations for Generative Artificial Intelligence in Plastic Surgery.

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

A general framework for governing marketed AI/ML medical devices.

This project represents the first systematic assessment of the US Food and Drug Administration's pos...

Comprehensive plant health monitoring: expert-level assessment with spatio-temporal image data.

Maintaining crop health is essential for global food security, yet traditional plant monitoring meth...

Optimizing Artificial Intelligence Thresholds for Mammographic Lesion Detection: A Retrospective Study on Diagnostic Performance and Radiologist-Artificial Intelligence Discordance.

Artificial intelligence (AI)-based systems are increasingly being used to assist radiologists in de...

Deep Learning-Assisted Microscopic Polarization Inspection of Micro-Nano Damage Precursors: Automatic, Non-Destructive Metrology for Additive Manufacturing Devices.

Additive Manufacturing (AM), as a revolutionary breakthrough in advanced manufacturing paradigms, le...

Gut microbiota, metabolites, and pulmonary hypertension: Mutual regulation and potential therapies.

Pulmonary hypertension is a progressive condition characterized by increased pulmonary vascular pres...

A Review of Software in Clinical Trials: FDA Regulatory Frameworks and Addressing Challenges.

An essential tool for assessing the efficacy and safety of novel therapies and interventions is the ...