FDA General

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

Artificial intelligence is rapidly transforming healthcare, offering promising advancements in diagnosis, treatment, and patient outcomes. However, concerns regarding the regulatory oversight of artificial intelligence driven medical technologies have emerged, particularly with the U.S. Food and Drug Administration's current approval processes. This paper critically examines the U.S. Food and Drug...

Identifying dynamic regulation with machine learning using adversarial surrogates.

Biological systems maintain stability of their function in spite of external and internal perturbations. An important challenge in studying biological regulation is to identify the control objectives based on empirical data. Very often these objectives are time-varying, and require the regulation system to follow a dynamic set-point. For example, the sleep-wake cycle varies according to the 24 hou...

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

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-based processes operating at different scales. Th...

Ethical Considerations for Generative Artificial Intelligence in Plastic Surgery.

The integration of artificial intelligence (AI) into surgical care is rapidly transforming healthcare by enhancing efficiency, clinical decision-makin...

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 postmarket surveillance of legally marketed artificia...

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 methods based on manual inspection are labor-intensive...

Leashes, not guardrails: A management-based approach to artificial intelligence risk regulation.

Calls to regulate artificial intelligence (AI) have sought to establish guardrails to protect the public against AI going awry. Although physical guar...

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 clinical trial. They are crucial for understanding...

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, leverages its unique layer-by-layer construction adv...

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 detecting breast cancer on mammograms. However, appl...

Synthetic data in medicine: Legal and ethical considerations for patient profiling.

Synthetic data is increasingly used in healthcare to facilitate privacy-preserving research, algorithm training, and patient profiling. By mimicking t...

Surgery without distance: will 5G-based robot-assisted telesurgery redefine modern surgery?

The rapid advancement of the 5G technology is catalyzing a paradigm shift in the realm of remote surgery, offering the potential to overcome geographi...

Digital Technology Prediction of Anger, Aggression, and Violence: Recent Innovations and Methodological Considerations.

Data derived from smartphone and wearable devices, combined with artificial intelligence/machine learning, have great potential to predict, detect, an...

Regulating the future of laboratory medicine: European regulatory landscape of AI-driven medical device software in laboratory medicine.

Artificial intelligence (AI) is rapidly transforming laboratory medicine, impacting medical devices and healthcare practices. Despite these advancemen...

Drug repurposing to identify potential FDA-approved drugs targeting three main angiogenesis receptors through a deep learning framework.

Tumor cell survival depends on the presence of oxygen and nutrients provided by existing blood vessels, particularly when cancer is in its early stage...

In-silico evaluation of Azadirachta indica-derived Daucosterol against key viral proteins of Ebolavirus using ML and MD simulations approach.

Ebola virus disease (EVD) is an acute life-threatening disease caused by highly pathogenic Ebolavirus (EBOV), with reported case fatality rates reachi...

Personalized dose reduction strategies for biologic disease-modifying antirheumatic drugs for treating axial spondyloarthritis: a clinical and economic evaluation with predictive modeling.

BACKGROUND: Axial spondyloarthritis (AS) is a chronic inflammatory disease that significantly affects quality of life and imposes a high economic burd...

Inorganic Biomaterials Inducing Scaffolds Pre-Neuralization for Infarcted Myocardium Repair.

Neural networks are found to play an important role in monitoring and coordinating cardiac physiological activities. However, the clinical use of neur...

The Role of Hydrogen Sulfide in the Localization and Structural-Functional Organization of p53 Following Traumatic Brain Injury: Development of a YOLO Model for Detection and Quantification of Apoptotic Nuclei.

Traumatic brain injury (TBI) triggers a cascade of molecular and cellular disturbances, including apoptosis, inflammation, and destabilization of neur...