US Food and Drug Administration Approval of High-risk Cardiovascular Devices for Use in Children and Adolescents, 1977-2021.

This study uses data from US Food and Drug Administration (FDA) databases to quantify approval of high-risk cardiovascular devices for use in pediatric populations and assess the clinical evidence supporting the approvals.

Adverse Drug Event Detection from Electronic Health Records Using Hierarchical Recurrent Neural Networks with Dual-Level Embedding.

Introduction: Adverse drug event (ADE) detection is a vital step towards effective pharmacovigilance and prevention of future incidents caused by potentially harmful ADEs. The electronic health records (EHRs) of patients in hospitals contain valuable information regarding ADEs and hence are an important source for detecting ADE signals. However, EHR texts tend to be noisy.