Analysis of relevant entries from public regulatory databases reveals use of pig, sheep, monkey, dog, and goat animal models with deep brain, peripheral nerve, muscle and spinal cord electrode placement with a variety of stimulation durations (hours to years); frequencies (10-10,000 Hz) and magnitud …

Part of the mission of the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration is to facilitate medical device innovation. Therefore, CDRH plays an important role in helping its stakeholders such as manufacturers, health care professionals, patients, patient advo …

An efficient process for the purification of synthetic phosphorothioate and native DNA sequences is presented. The process is based on the use of an aminopropylated silica gel support functionalized with aminooxyalkyl functions to enable capture of DNA sequences through an oximation reaction with th …

Reliable acoustic characterization is fundamental for patient safety and clinical efficacy during high-intensity therapeutic ultrasound (HITU) treatment. Technical challenges, such as measurement variation and signal analysis, still exist for HITU exposimetry using ultrasound hydrophones. In this wo …

Cyclosporine A (CsA) is an immunosuppressive drug commonly used in organ transplant patients to prevent allograft rejections. Ketamine is a pediatric anesthetic that noncompetitively inhibits the calcium-permeable N-methyl-d-aspartic acid receptors. Adverse drug-drug interaction effects between keta …

Expanded access, also called "compassionate use," provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options …

The ability of adolescents to access safe and effective new products for HIV prevention and treatment is optimised by adolescent licensure at the same time these products are approved and marketed for adults. Many adolescent product development programmes for HIV prevention or treatment products may …

New technologies challenge current dialysis treatment paradigms as devices become smaller, more portable, and increasingly used outside the dialysis clinic. It is unclear how patients will view this care transition, and it will be important to consider patient and care partner perspectives during al …

The results of this study suggest that specific information about feed position and field orientation direction must be considered for an accurate evaluation of patient exposure. Magn Reson Med 79:1135-1144, 2018. © 2017 International Society for Magnetic Resonance in Medicine.

Albumax medium may facilitate or support better morphology and spermatid production than KSR medium. Further studies need to improve spermatid production and refinement of this in vitro testis culture system that may be useful as a supplement to current male reproductive toxicity testing or an alter …

This study investigates how the tuning conditions of a 64 MHz / 1.5 T radio frequency (RF) birdcage coil modeled with an RF circuit and 3D electromagnetic co-simulation affect the electric and magnetic near-field distribution. Four models were implemented with different tuning conditions and differe …

Viral and Bacterial Co-Infection and Its Implications

Magnetic Resonance Imaging (MRI) is a radiological imaging technique widely used in clinical practice. MRI has been proposed to guide the catheters for interventional procedures, such as cardiac ablation. However, there are risks associated with this procedure, such as RF-induced heating of tissue n …

The sense of prosthesis embodiment, or the feeling that the device has been incorporated into a user's body image, may be enhanced by emerging technology such as invasive electrical stimulation for sensory feedback. In turn, prosthesis embodiment may be linked to increased prosthesis use and improve …

The needs of individuals with upper limb amputation and congenital limb difference are not being fully met by current prostheses, as evidenced by prosthesis rejection, non-wear, and user reports of pain and challenging activities. Emerging technologies such as dexterous sensorized robotic limbs, oss …

This study fills a gap in the literature by assessing the absolute harm perceptions of a variety of traditional and alternative tobacco products. Harm perceptions vary among tobacco products, and the relationship among tobacco use, information seeking, thoughts about chemicals in tobacco products, a …

Importance of Substrate-Coupled Proton Antiport by the Vesicular Monoamine Transporter in the Actions of Amphetamines in Drosophila Brain

Regulatory watch: The target product profile as a tool for regulatory communication: advantageous but underused

Medication nonadherence, a major problem in cardiovascular disease (CVD), contributes yearly to approximately 125,000 preventable deaths, which is partly attributable to only about one-half of CVD patients consistently taking prescribed life-saving medications. Current interest has focused on how la …

We have investigated the potential for contrast-enhanced near-infrared fluorescence imaging of tissue on a mobile phone platform. Charge-coupled device- and phone-based cameras were used to image molded and three-dimensional-printed tissue phantoms, and an ex vivo animal model. Quantitative and qual …

The performance of a classifier is largely dependent on the size and representativeness of data used for its training. In circumstances where accumulation and/or labeling of training samples is difficult or expensive, such as medical applications, data augmentation can potentially be used to allevia …

Wide-angle parabolic models are commonly used in geophysics and underwater acoustics but have seen little application in medical ultrasound. Here, a wide-angle model for continuous-wave high-intensity ultrasound beams is derived, which approximates the diffraction process more accurately than the co …

Lack of Effects of Toll-Like Receptor 4 Antagonists on the Reinforcing Effects of Cocaine and Remifentanil

As technologies evolve, and diagnostics move from detection of single biomarkers toward complex signatures, an increase in the clinical use and regulatory submission of complex signatures is anticipated. However, to date, no complex signatures have been approved as companion diagnostics. In this art …

Acid hydrolyzed vegetable protein (aHVP) is used for flavoring a wide variety of foods and also in the production of nonfermented soy sauce. During the production of aHVP, chloropropanols including 3-monochloropropane-1,2-diol (3-MCPD) and 1,3 dichloropropane-2-ol (1,3-DCP) can be formed through the …

Both regulatory science and clinical practice rely on data-driven approaches to guide decision making; however, additional factors are also important in clinical practice that do not impact regulatory decision making, and these considerations may result in heterogeneity in clinical uptake of pharmac …

The expanded access program is viewed as a success from FDA's perspective based on the large number of applications processed and allowed to proceed each year. However, the actual number of patients and their health care providers that desire drug treatments available under expanded access is not kn …

The enrollment of adolescents with cancer in clinical trials is much lower than that of younger pediatric patients. For adolescents with "adult-type" cancers, lack of access to relevant trials is cited as one of the reasons for this discrepancy. Adolescents are generally not eligible for enrollment …