Recalls of Moderate- and High-Risk Otolaryngologic Devices Approved by the US Food and Drug Administration, 2003-2019.

Objective: The US Food and Drug Administration (FDA) regulates the marketing of medical devices based on the premarket approval (PMA) or 510(k) pathway. We investigated the relationship among the regulatory pathway of otolaryngologic devices, the number of recalls, and the recall characteristics.

Study Design: Retrospective cross-sectional analysis.

VE/VCO2 slope predicts RV dysfunction and mortality after left ventricular assist device: a fresh look at cardiopulmonary stress testing for prognostication.

Preoperative cardiopulmonary exercise testing (CPET) is well validated for prognostication before advanced surgical heart failure therapies, but its role in prognostication after LVAD surgery has never been studied. VE/VCO2 slope is an important component of CPET which has direct pathophysiologic links to right ventricular (RV) performance. We hypothesized that VE/VCO slope would prognosticate RV dysfunction after LVAD.

Quantitative Analysis of Enhanced Selfies in a Young Adult Population.

The use of filters and editing tools for perfecting selfies is increasing. While some aesthetic experts have touted the ability of this technology to help patients convey their aesthetic goals, others have expressed concerns about the unrealistic expectations that may come from the ability for individuals to digitally alter their own photos in these so-called "super-selfies." The aim of the study is to determine the changes that individuals seek when enhancing selfies.

Cinebot: Creation of Movies and Animated GIFs Directly from PACS-Efficiency in Presentation and Education.

The presentation of radiology exams can be enhanced through the use of dynamic images. Dynamic images differ from static images by the use of animation and are especially useful for depicting real-time activity such as the scrolling or the flow of contrast to enhance pathology. This is generally superior to a collection of static images as a representation of clinical workflow and provides a more robust appreciation of the case in question.

Developing Deeper Radiology Exam Insight to Optimize MRI Workflow and Patient Experience.

Process variability during the acquisition of magnetic resonance imaging (MRI) can lengthen examination times and introduce unexpected exam differences which can negatively impact the cost and quality of care provided to patients. Digital Imaging and Communications in Medicine (DICOM) metadata can provide more accurate study data and granular series-level information that can be used to increase operational efficiency, optimize patient care, and reduce costs associated with MRI examinations. Systematic use of such data analysis could be used as a continuous operational optimization and quality control mechanism.

Microfluidic purification and concentration of malignant pleural effusions for improved molecular and cytomorphological diagnostics.

Evaluation of pleural fluids for metastatic cells is a key component of diagnostic cytopathology. However, a large background of smaller leukocytes and/or erythrocytes can make accurate diagnosis difficult and reduce specificity in identification of mutations of interest for targeted anti-cancer therapies. Here, we describe an automated microfluidic system (Centrifuge Chip) which employs microscale vortices for the size-based isolation and concentration of cancer cells and mesothelial cells from a background of blood cells.