FDA General

Revolutionizing Liver Imaging: Artificial Intelligence-Driven Advances in Diagnostics and Staging.

Artificial intelligence (AI) has emerged as a transformative tool in liver imaging, offering enhanced diagnostic accuracy, efficiency, and reproducibility. The integration of machine learning and deep learning algorithms into radiological workflows has shown significant promise across a wide range of liver diseases. Key applications include automated liver segmentation on computed tomography (CT) ...

Recent advances in cancer nanomedicine: From smart targeting to personalized therapeutics - pioneering a new era in precision oncology.

Cancer nanomedicine has evolved from the 1995 landmark approval of Doxil® into a programmable platform of precision oncology. The field now progresses along a coherent continuum that begins with passive enhanced permeability and retention (EPR)-mediated tumor accumulation, advances to active ligand-receptor targeting, and culminates in stimuli-responsive carriers whose cargo is liberated only when...

Transcriptome-wide RNA Stability Across Cancers Reveals Therapeutic Vulnerabilities.

The steady-state abundance of mRNA is governed by the interplay between transcription and degradation, yet the contribution of RNA stability to cancer...

Thermal imaging-guided detection of transparent plastic contaminants on chicken breast: A combined vision and simulation approach.

Poultry consumption has surged in recent years, raising food safety concerns from foreign material (FM) contamination, particularly transparent plasti...

Artificial Intelligence in Prostate MRI: Addressing Current Limitations Through Emerging Technologies.

Prostate MRI has transformed lesion detection and risk stratification in prostate cancer, but its impact is constrained by the high cost of the exam, ...

Alternative splicing in cancer drug resistance: Mechanisms and therapeutic prospects (Review).

Alternative splicing (AS) is one of the principal mechanisms of post‑transcriptional regulation that confers transcriptomic plasticity and proteomic d...

Environmental exposures, epithelial barrier dysfunction, and the evolving landscape of allergic disorders and asthma.

PURPOSE OF REVIEW: Immediate hypersensitivity disorders, such as asthma, food intolerance, and anaphylaxis, have risen dramatically since the 20th cen...

Morphologic Evaluation of Hyperchromatic Crowded Groups Present in Cervical Thin Prep Cytology Tests as Identified by the Hologic Genius Digital Diagnostics System: A Descriptive Study.

BACKGROUND: Our descriptive study focused on morphologic characteristics of hyperchromatic crowded groups (HCGs) in ThinPrep cervical cytology tests w...

Prediction of IDH-mutation and 1p19q-codeletion status in adult-type diffuse gliomas using three-class radiomics models.

PURPOSE: To predict the genetic subtypes of adult-type diffuse gliomas with three-class MRI radiomics. MATERIAL AND METHODS: Four hundred and eighty p...

Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation.

BACKGROUND: Artificial intelligence (AI) and machine-learning (ML) technologies are increasingly being incorporated into orthopaedic medical devices, ...

Programmable materials: A comprehensive review on shape memory polymers for orthopedic applications.

Shape memory polymers (SMP) are smart, active polymers, which can significantly change their properties by external stimuli such as heat or temperatur...

Prospective validation of deep-learning algorithms for diabetic retinopathy screening: A systematic review and meta-analysis.

Deep-learning (DL) algorithms are widely promoted for diabetic-retinopathy (DR) screening, yet their prospective diagnostic accuracy is not well defin...

Molecular crystal memristor-based edge AI platform for energy-efficient and real-time smart grid inspection.

Vast power grid infrastructure generates enormous volumes of inspection data from smart meters, unmanned aerial vehicle (UAV) patrols, and high-defini...

Propagation mapping using iterative independent component analysis for seizure onset zone localization in temporal lobe epilepsy.

BACKGROUND: Epilepsy affects approximately 70 million people worldwide, with a third of them being drug-resistant and requiring surgical intervention....

Companion diagnostic: An overview of regulatory framework, challenges, and future directions.

In era of precision medicine, companion diagnostic (CDx) is prominent tool that links the gaps between diagnostics and therapeutics based on biomarker...

Combatting antimicrobial-resistant Neisseria gonorrhoeae: new antibiotics and the pipeline of antigonococcal therapeutics.

PURPOSE OF REVIEW: Gonorrhea is the second most prevalent bacterial sexually transmitted infection globally. The proliferation of antimicrobial-resist...

Machine learning-augmented metaproteomics reveals metabolic adaptation of anammox bacteria under high nitrogen loading rate.

Anaerobic ammonium oxidation (anammox) is a biological process in which NH4+ serves as the electron donor and NO2- as the electron acceptor to produce...

Identification of common genetic features and pathways for osteoporosis with frozen shoulder by integrated bioinformatics analysis and machine learning.

Frozen shoulder (FS) and osteoporosis (OP) are common age-related degenerative diseases, occurring more frequently in females, which suggests potentia...

Guiding design and performance of nonviral nucleic acid delivery vehicles via machine learning.

Machine Learning (ML) techniques have enabled the advancement of many technologies throughout the pharmaceutical industry, especially for drug discove...

Regulatory Challenges and Opportunities: A Review of U.S. Food and Drug Administration-Approved Artificial Intelligence and Machine Learning-Enabled Cardiovascular Devices.

The integration of artificial intelligence (AI) and machine learning (ML) into medical devices has revolutionized healthcare, enhancing diagnostic acc...