The U.S. Food and Drug Administration (FDA) is charged with assuring the safety and effectiveness of medical devices. Before any medical device can be brought to market, it must comply with all federal regulations regarding FDA processes for clearance or approval. Navigating the FDA regulatory proce …

Electrical stimulation is a fundamental tool in studying neural circuits, treating neurological diseases, and advancing regenerative medicine. Injectable, free-standing piezoelectric particle systems have emerged as non-genetic and wireless alternatives for electrode-based tethered stimulation syste …

These results demonstrate the unique performances of the new probe while also suggesting that intact retinas retain better stability and robustness than ex-vivo retinas making them more suitable for characterizing retina responses to electrical stimulation.

Contractile forces within the planar interface between T cell and antigen-presenting surface mechanically stimulate T cell receptors (TCR) in the mature immune synapses. However, the origin of mechanical stimulation during the initial, i.e., presynaptic, microvilli-based TCR activation in the course …

High-throughput next generation sequencing (NGS) is a shotgun approach applied in a parallel fashion by which the genome is fragmented and sequenced through small pieces and then analyzed either by aligning to a known reference genome or by de novo assembly without reference genome. This technology …

Background. Previous research found that adding a single piece of quantitative information about prescription drug benefits to direct-to-consumer (DTC) ads helps consumers understand how well the drug works. However, drug information often includes quantitative information on multiple benefit …

Direct-to-consumer websites for brand-name accelerated approval prescription drugs do not consistently communicate the accelerated approval information for the product to consumers in a prominent, comprehensive, or readable manner.

To assess the utility of human-induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) as an in vitro proarrhythmia model, we evaluated the concentration dependence and sources of variability of electrophysiologic responses to 28 drugs linked to low, intermediate, and high torsades de point …

In some clinical settings such as the cancer immunotherapy trials, a treatment time-lag effect may be present and the lag duration possibly vary from subject to subject. An efficient study design and analysis procedure should not only take into account the time-lag effect but also consider the indiv …

Time delay spectrometry (TDS) is extended for broadband characterization of plastics (low-density polyethylene, LDPE) and tissue-mimicking material (TMM). The results suggest that TDS and the conventional broadband pulse method give comparable measurements for frequency-dependent attenuation coeffic …

Directivity is a hydrophone specification that describes response as a function of angle of incidence. The goal of this study was to compare, in the context of needle hydrophones, the commonly used rigid baffle model for hydrophone directivity to three alternative models: soft baffle, unbaffled (UB) …

Little is known about nicotine and addiction beliefs held by those who are foreign-born in the US and how these beliefs are associated with acculturation and race/ethnicity. This study attempts to address these research gaps. Data were analyzed from two cycles of the Health Information National Tren …

Anecdotal evidence indicates that naloxone prices have risen in recent years, but limited research has examined the magnitude of these increases and potential causes. We contribute nationally representative evidence to help answer each of these questions, including wholesale pricing data from a prop …

This paper presents a physiological model to reproduce hemodynamic responses to blood volume perturbation. The model consists of three sub-models: a control-theoretic model relating blood volume response to blood volume perturbation; a simple physics-based model relating blood volume to stroke volum …

The Biomarker Qualification Program was established at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) to expedite the integration of promising biomarkers across multiple drug development programs. The first set of biomarkers qualified in 2008 consisted of seve …

The US Food and Drug Administration's (FDA's) generic drug program has dramatically increased the availability of affordable, high quality generic drugs. The foundation of generic drug approvals is a two-tiered regulatory framework of pharmaceutical equivalence and bioequivalence. Intrinsic to both …

Neuraminidase (NA) plays an essential role in influenza virus replication, facilitating multicycle infection predominantly by releasing virions from infected cells. NA-inhibiting antibodies provide resistance to disease and NA-specific antibodies contribute to vaccine efficacy. The primary reason NA …

This study investigates the use of pads with high dielectric constant (HDC) materials to alter electromagnetic field distributions in patients during magnetic resonance imaging (MRI). The study was performed with numerical simulations and phantom measurements. An initial proof-of-concept and validat …

The total product life cycle (TPLC) of medical devices has been defined by four stages: discovery and ideation, regulatory decision, product launch, and postmarket monitoring. Manufacturers of medical devices intended for use in the peripheral vasculature, such as stents, inferior vena cava (IVC) fi …

Needle and fiber-optic hydrophones have frequency-dependent sensitivity, which can result in substantial distortion of nonlinear or broadband pressure pulses. A rigid cylinder model for needle and fiber-optic hydrophones was used to predict this distortion. The model was compared with measurements o …

Evaluating risk of fatigue fractures in cardiovascular implants via nonclinical testing is essential to provide an indication of their durability. This is generally accomplished by experimental accelerated durability testing and often complemented with computational simulations to calculate fatigue …

Electrochemistry of a Robust Neural Interface

Monoclonal antibody production in commercial scale cell culture bioprocessing requires a thorough understanding of the engineering process and components used throughout manufacturing. It is important to identify high impact components early on during the lifecycle of a biotechnology-derived product …

Short interval performance metrics can provide insights on the potential of a beat detector to generate incorrect heart rate limit alarms.

Blacks are two to three times as likely as whites to die of preventable heart disease and stroke. Declines in mortality from heart disease have not eliminated racial disparities. Control and effective treatment of hypertension, a leading cause of cardiovascular disease, among blacks is less than in …

The FDA recently completed a study on design methodologies surrounding the Validation of Imaging Premarket Evaluation and Regulation called VIPER. VIPER consisted of five large reader sub-studies to compare the impact of different study populations on reader behavi …

A portable CeBr3 based gamma-ray detection system was designed and built for rapid turnaround, high throughput, real-time, and in situ sample analysis. The new technique allows automated data transmission from the field unit to a central laboratory controller to ensure laboratory quality …

Particle size distribution, a measurable physicochemical quantity, is a critical quality attribute of drug products that needs to be controlled in drug manufacturing. The non-invasive methods of dynamic light scattering (DLS) and Diffusion Ordered SpectroscopY (DOSY) NMR can be used to measure diffu …