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Anderson Rockford C - - 2006
The use of inferior vena cava (IVC) filters is increasing rapidly, and the recent availability of retrievable IVC filters is certain to accelerate this process. Unfortunately, because the risks and benefits of these devices have not been adequately studied, several important issues remain. Limitations of the quality of the data ...
Keida Tomoko - - 2006
The American Food and Drug Administration (FDA) bioequivalent guidance of topical dermatological corticosteroids in 1995 (the Guidance) requires measurement of the skin blanching response with a chromameter for evaluation of cutaneously applied corticosteroid formulations. The Japanese government decided to apply the same guidelines in 2003, despite there having been no ...
Nguyen Minh Nhut - - 2006
As an associative memory neural network model, the cerebellar model articulation controller (CMAC) has attractive properties of fast learning and simple computation, but its rigid structure makes it difficult to approximate certain functions. This research attempts to construct a novel neural fuzzy CMAC, in which Bayesian Ying-Yang (BYY) learning is ...
Unal Murat - - 2006
A tracheoesophageal voice prosthesis is highly effective in promoting good speech after total laryngectomy. However, long-term use of this device occasionally results in the development of fistulas that must be closed, usually at the request of the patient, because of leakage of saliva and food around the prosthesis. This report ...
Delaney Jeffrey W - - 2006
The GORE HELEX Septal Occluder (W.L. Gore and Associates, Flagstaff, Ariz, USA) is the latest device to pursue U.S. Food and Drug Administration (FDA) approval for the closure of secundum atrial septal defects. The device is soft and compliant with comparatively little metal framework. It can be deployed and retrieved ...
Yakuphanoglu F - - 2006
The electrical, optical, and metal-semiconductor contact properties of the polyaniline prepared by emulsion polymerization have been investigated to obtain an organic semiconductor material. The obtained results suggest that the polyaniline (PANI) studied is an organic semiconductor material with optical band gap (E(g) = 2.21 eV) and room electrical conductivity (sigma(25) ...
Shah Jignesh S - - 2006
CONTEXT: Automated external defibrillators (AEDs) play a key role in the community resuscitation of persons with cardiac arrest and are of proven clinical benefit. Although AEDs are complex medical devices designed to function during life-threatening emergencies, little is known about their reliability. OBJECTIVES: To determine the number and rate of ...
Elvira L - - 2006
An eight-channel ultrasonic detecting device for microbiological quality evaluation of packed liquid foods is presented in this paper. This device makes possible a non-invasive detection of the microbial growth in liquid foods with no need to open the carton-based packages where they are contained. Thermal and humidity stabilization are required ...
Fink James B - - 2006
Helium-oxygen mixture (heliox) has been advocated for clinical use since 1934, and there has been a growing array of clinical applications. Until recently, administering heliox has required jury-rigging by modifications and/or extension of available devices not designed for use with heliox. This paper reviews devices required to administer heliox and ...
Terranova F - - 2006
Only a limited number of studies on cellulite have been published in the international literature and many of them reach somewhat antithetical conclusions. Consequently, it is not yet possible to reconcile the extreme differences of opinion which have lingered on for years concerning the nature of this disorder, as well ...
- - 2006
The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule that amended the regulation authorizing a health claim on the relationship between beta-glucan soluble fiber from whole oat sources and reduced risk of coronary heart disease (CHD) by adding ...
Brown Stephen D - - 2006
PURPOSE: To retrospectively characterize the extent and nature of financial relationships with industry that are disclosed in the abstracts of scientific papers presented at the 2003 Radiological Society of North America (RSNA) Annual Meeting and to retrospectively assess whether the presence of relationships between researchers and industry was associated with ...
Chang Chieh - - 2006
The cytoplasmic C. elegans protein MIG-10 affects cell migrations and is related to mammalian proteins that bind phospholipids and Ena/VASP actin regulators. In cultured cells, mammalian MIG-10 promotes lamellipodial growth and Ena/VASP proteins induce filopodia. We show here that during neuronal development, mig-10 and the C. elegans Ena/VASP homolog unc-34 ...
Petersilge Cheryl A - - 2006
Lumbar disc replacement is a developing primary surgical treatment for patients with degenerative disc disease. The goals of disc arthroplasty are to remove the native nucleus pulposus and to preserve motion at that disc level. Devices being developed include artificial replacement of the nucleus pulposus and artificial replacement of the ...
Cho Jae-Sung - - 2006
Although many thoracic endografts are commercially available in Europe, only three such devices have been introduced to the United States. Gore TAG endoprosthesis was the first to enter clinical trials in the United States for treatment of descending thoracic aortic aneurysm, and gained the approval of the US Food and ...
Donawa Maria - - 2006
There is no official form for submitting a United States premarket notification or 510(k) submission. A recent Food and Drug Administration guidance document describes the manner in which this type of premarket submission should be formatted. This article discusses this document and so me important aspects of the 510(k) process.
Yun Sang H - - 2006
In this work, we demonstrate that boron nanowire Y-junctions can be synthesized in a self-assembled manner by fusing two individual boron nanowires grown inclined toward each other. We show that the presence of a second liquid, in addition to the liquid Au catalyst, is critical to the inclination of the ...
Abazov V M - - 2006
We present a search for the standard model Higgs boson in H --> WW(*) decays with e+e-, e+/-mu-/+, and mu+mu- final states in pp collisions at a center-of-mass energy of square root of s = 1.96 TeV. The data, collected from April 2002 to June 2004 with the D0 detector, ...
Román I - - 2006
In this paper we introduce an ontology that covers all the terminology involved in the ODP standard. This ontology has been extended with concepts taken from the prEN12967 in order to apply it in the healthcare domain. Describing components formally and using this ontology, their semantic integration can be eased ...
Cooper Jason G - - 2006
Software assurance is a rigorous, lifecycle phase-independent set of activities which ensure completeness, safety, and reliability of software processes and products. This is accomplished by guaranteeing conformance to all requirements, standards, procedures, and regulations. These assurance processes are even more important when coupled with healthcare software systems, embedded software in ...
O'Neill Adrian T AT Dept. of Biomed. Eng., North Carolina Univ., Chapel Hill, NC, USA. - - 2006
A novel microfluidic device is presented which creates a linear serial dilution of two input fluid streams. This platform facilitates higher productivity as a component of a high throughput cytotoxicity testing strategy. A modeling solution is presented to create custom linear dilution schemes. The featured device creates a serial dilution ...
- - 2005
The Food and Drug Administration (FDA) is classifying the low energy ultrasound wound cleaner into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner." The agency is taking this action ...
- - 2005
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals ...
Stier Byron G - - 2006
The report of the Hemorrhagic Stroke Project (HSP), a case-control study of phenylpropanolamine (PPA) was the primary reason that the US Food and Drug Administration (FDA) requested that PPA-containing products voluntarily be withdrawn from the market. In subsequent litigation, scientific information emerged that was not available during the deliberations of ...
- - 2005
The Food and Drug Administration (FDA) is classifying AFP-L3% (alpha-fetoprotein L3 subfraction) immunological test systems into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: AFP-L3% Immunological Test Systems." The agency is classifying the device ...
Oldenziel Weite H - - 2005
Amperometric hydrogel-coated glutamate microsensors form a promising concept to detect glutamate levels directly in brain tissue. These microsensors are constructed by coating a carbon fiber electrode (CFE) (10 microm diameter; 300-500 microm long) with a five-component redox-hydrogel, in which L-glutamate oxidase, horseradish peroxidase, and ascorbate oxidase are wired via poly(ethylene ...
- - 2005
The Food and Drug Administration (FDA) is classifying ribonucleic acid (RNA) preanalytical systems into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization, and Purification Systems for RT-PCR Used ...
Church James - - 2005
PURPOSE: The technology of the seven-minute scientific presentation has changed greatly with the universal acceptance of computerized slides and graphics. We performed this study to see whether the quality of delivery has improved pari passu with technical advances in presentation of data. METHODS: In 1993 and in 2003 a sample ...
Eplan Harlan - - 2005
The City of New York Department of Health and Mental Hygiene (DOHMH) wanted to improve both emergency environmental monitoring and reporting for environmental incidents (e.g., bio-terrorism, accidents, etc.) and day-to-day field inspections. The data collection technique in place required responders to collect readings using commonly used mobile environmental and radiological ...
Nguyen Thoi D - - 2005
In everyday life, a macroscopic valve is a device with a movable control element that regulates the flow of gases or liquids by blocking and opening passageways. Construction of such a device on the nanoscale level requires (i) suitably proportioned movable control elements, (ii) a method for operating them on ...
Rogers Cindy J - - 2005
The modern formulation of dihydroxyacetone (DHA), the only sunless tanning solution approved by the Food and Drug Administration (FDA), is combined with bronzers and moisturizers to deliver a cosmetically acceptable skin color and a natural-looking tan without ultraviolet (UV) exposure. Spray-on tanning products, which deliver this formulation evenly to achieve ...
- - 2005
The Food and Drug Administration (FDA) is issuing a final rule to amend the Federal performance standard for diagnostic x-ray systems and their major components (the performance standard). The agency is taking this action to update the performance standard to account for changes in technology and use of radiographic and ...
Heckman Jerome H - - 2005
The regulation of food packaging has, indeed, become a global subject as the world's commercial channels have broadened since World War II. The first comprehensive regulatory statute governing the area was the Food Additives Amendment of 1958 in the United States, a modification of the 1938 Federal Food, Drug, and ...
Henderson Jennifer A - - 2005
The radiology community has an ever-expanding array of technologies to use in the care of patients. Regulated by the US Food and Drug Administration, these technologies often raise complex regulatory and legal questions in everyday practice that can be daunting for practicing radiologists. This article reviews the federal medical device ...
- - 2005
The Food and Drug Administration (FDA) is issuing an interim final rule to amend certain regulations regarding the screening and testing of donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. FDA is taking this action in response to comments from affected interested persons regarding ...
Pelletier David L - - 2005
The US Food and Drug Administration's (FDA's) 1992 policy statement was developed in the context of critical gaps in scientific knowledge concerning the compositional effects of genetic transformation and severe limitations in methods for safety testing. FDA acknowledged that pleiotropy and insertional mutagenesis may cause unintended changes, but it was ...
- - 2005
The Food and Drug Administration (FDA) is amending its regulation on the use of ozone-depleting substances (ODSs) in self-pressurized containers to remove the essential-use designations for albuterol used in oral pressurized metered-dose inhalers (MDIs). Under the Clean Air Act, FDA, in consultation with the Environmental Protection Agency (EPA), is required ...
Yan He - - 2005
This contribution describes an organosiloxane cross-linking approach to robust, efficient, adherent hole-transport layers (HTLs) for polymer light-emitting diodes (PLEDs). An example is 4,4'-bis[(p-trichlorosilylpropylphenyl)phenylamino]biphenyl (TPDSi(2)), which combines the hole-transporting efficiency of N,N-diphenyl-N,N-bis(3-methylphenyl)-1,1-biphenyl)-4,4-diamine) (TPD, prototypical small-molecule HTL material) and the strong cross-linking/densification tendencies of organosilanol groups. Covalent chemical bonding of TPDSi(2) to ...
Deitcher Steven R - - 2005
Alfimeprase (ALF) is a recombinant, truncated form of fibrolase, a directly fibrinolytic zinc metalloproteinase that was first isolated from the venom of the Southern copperhead snake (Agkistrodon contortrix contortrix). ALF has direct proteolytic activity against the fibrin(ogen) Aalpha chain. ALF can be covalently bound and neutralized by serum alpha2-macroglobulin, a ...
Labrecque Michel - - 2005
Simple ligation of the vas with suture material and excision of a small vas segment is believed to be the most common vasectomy occlusion technique performed in low-resource settings. Ligation and excision (LE) is associated with a risk of occlusion and contraceptive failure which can be reduced by performing fascial ...
- - 2004
The Food and Drug Administration (FDA) is issuing a final rule to reclassify two embolization device types from class III (premarket approval) into class II (special controls). The agency is also changing the names and revising the identifications of these devices. The vascular embolization device (previously the arterial embolization device) ...
- - 2004
The Food and Drug Administration (FDA) is classifying external penile rigidity devices intended to create or maintain sufficient penile rigidity for sexual intercourse into class II (special controls). FDA also is exempting these devices from premarket notification requirements. Elsewhere in this issue of the Federal Register, FDA is announcing the ...
- - 2004
The Food and Drug Administration (FDA) is classifying the assisted reproduction laser system into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems." The agency is classifying this device into class ...
- - 2004
The Food and Drug Administration (FDA) is issuing a final regulation that requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and ...
- - 2004
The Food and Drug Administration is amending the identification and classification regulations of gold-based alloys and precious metal alloys for clinical use and base alloys devices in order to designate a special control for these devices. FDA is also exempting these devices from premarket notification requirements. The agency is taking ...
- - 2004
The Food and Drug Administration (FDA) is classifying silicone sheeting intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars into class I (general controls). As a class I device, the device will be exempt from premarket notification requirements. This action is taken under the Federal Food, ...
Sobieski Michael A - - 2004
The purpose of this study was to test the operational effectiveness of the Thoratec mobile computer for monitoring and adjusting the portable TLC-II pneumatic driver. The TLC-II portable driver is approved by the Food and Drug Administration for use with either the paracorporeal ventricular assist device (VAD) or the Implantable ...
- - 2004
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M4: The CTD--Quality: Questions and Answers/Location Issues." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance provides further clarification ...
- - 2004
The Food and Drug Administration (FDA) is issuing a final regulation that provides procedures for the detention of an article of food, if an officer or qualified employee of FDA has credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to ...
Curty Marcos - - 2004
We demonstrate that a necessary precondition for an unconditionally secure quantum key distribution is that both sender and receiver can use the available measurement results to prove the presence of entanglement in a quantum state that is effectively distributed between them. One can thus systematically search for entanglement using the ...
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