In vitro test methods for evaluating high molecular weight polyethylene oxide polymer induced hemolytic and thrombotic potential.

To combat opioid abuse, the U.S. Food and Drug Administration (FDA) released a comprehensive action plan to address opioid addiction, abuse, and overdose that included increasing the prevalence of abuse-deterrent formulations (ADFs) in opioid tablets.

A Systematic Analysis of Recent Technology Trends of Microfluidic Medical Devices in the United States.

In recent years, the U.S. Food and Drug Administration (FDA) has seen an increase in microfluidic medical device submissions, likely stemming from recent advancements in microfluidic technologies.

Overcoming technological barriers in microfluidics: Leakage testing.

The miniaturization of laboratory procedures for Lab-on-Chip (LoC) devices and translation to various platforms such as single cell analysis or Organ-on-Chip (OoC) systems are revolutionizing the life sciences and biomedical fields. As a result, microfluidics is becoming a viable technology for improving the quality and sensitivity of critical processes. Yet, standard test methods have not yet been established to validate basic manufacturing steps, performance, and safety of microfluidic devices.

Comprehensive characterization of protective face coverings made from household fabrics.

Background: Face coverings constitute an important strategy for containing pandemics, such as COVID-19. Infection from airborne respiratory viruses including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) can occur in at least three modes; tiny and/or dried aerosols (typically < 1.0 μm) generated through multiple mechanisms including talking, breathing, singing, large droplets (> 0.

Assessment of Flow through Microchannels for Inertia-Based Sorting: Steps toward Microfluidic Medical Devices.

The development of new standardized test methods would allow for the consistent evaluation of microfluidic medical devices and enable high-quality products to reach the market faster. A comprehensive flow characterization study was conducted to identify regulatory knowledge gaps using a generic inertia-based spiral channel model for particle sorting and facilitate standards development in the microfluidics community. Testing was performed using 2-20 µm rigid particles to represent blood elements and flow rates of 200-5000 µL/min to assess the effects of flow-related factors on overall system performance.