Endovascular treatment of infrarenal abdominal aortic aneurysm (AAA) offers a less invasive alternative to conventional open repair. Currently, only four devices are Food and Drug Administration (FDA)-approved for use in endovascular aneurysm repair (EVAR) of AAA in the United States. All four devices are associated with a high technical success ...

The Food and Drug Administration (FDA) is classifying Plasmodium species antigen detection assays 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: Plasmodium Species Antigen Detection Assays." The agency is classifying the device into ...

Membrane processes are well-known for separating and fractionating suspensions in many industries, but suffer from particle accumulation on the membrane surface. Currently, there are new developments using microfluidic devices for cell/DNA sorting and fractionation. We anticipate these devices are also applicable to fractionation of polydisperse and concentrated suspensions (e.g. foods), ...

A simplified apparatus is described that measures the damping of a suspended measuring device. The movement of the device (bob) is damped by the properties of the air-water surface adsorbed material. Its value lies in describing the surface chemomechanical properties of ingredients and excipients used in food, nutraceutical, cosmetic (cosmeceutical), ...

OSHA is confirming the effective date of its direct final rule that revises a number of standards for general industry that refer to national consensus standards. The direct final rule states that it would become effective on March 13, 2008 unless OSHA receives significant adverse comment on these revisions by ...

Unfortunately, some medical device manufacturers, particularly those based outside the United States (US) are unaware of the business implications of submitting a 510(k) premarket notification to the US Food and Drug Administration. This article discusses information regarding the ownership and other business related aspects of filing a 510(k).

It cannot be disputed that in-house ('home brew') assays have a part to play in the diagnosis of emerging or evolving infections such as avian influenza H5N1. In such circumstances, diagnostic companies can provide Research Use Only (RUO) or analyte specific reagents (ASR) to facilitate development. In contrast, the provision ...

Since 1997, the US Food and Drug Administration has approved 5 global endometrial ablation (GEA) devices for the minimally invasive treatment of idiopathic menorrhagia. These include a variety of modalities to ablate the endometrium, including thermal balloon, circulated hot fluid, cryotherapy, radiofrequency electrosurgery, and microwave energy. Level I evidence is ...

The Food and Drug Administration (FDA) is amending the health claim regulation entitled "Soluble fiber from certain foods and risk of coronary heart disease (CHD)" to add barley betafiber as an additional eligible source of beta-glucan soluble fiber. Barley betafiber is the ethanol precipitated soluble fraction of cellulase and alpha-amylase ...

We report high performance organic field-effect transistors (OFETs) with the modified Cu bottom-contact electrodes. Efficient modification of the Cu electrodes with nanometer-size copper tetracyanoquinodimethane (Cu-TCNQ) increases the electrode/organic layer contact area and reduces contact resistance. We investigated the effect of the Cu-TCNQ morphology on the device performance. The pentacene-based OFETs ...

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 1: Residue on Ignition/Sulphated Ash General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical ...

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ...

PURPOSE OF REVIEW: Sinus surgery tools are constantly being developed. This review will focus on new devices (popularly called sinuplasty) for use in ostial dilation. RECENT FINDINGS: Balloons for sinus ostial dilation are approved by the Food and Drug Administration and are used worldwide. There have been presentations, publications and ...

Probiotics are living microorganisms that, when consumed, have the potential to confer a beneficial health effect. Unfortunately for purveyors of probiotic products, the system of regulation delineated in the Food, Drug, and Cosmetic Act is anything but "one size fits all." How a probiotic product is used or is intended ...

At any one time large numbers of people are attempting to control their weight. Women are the principal consumers of weight-control programs. Their options, outside the prescription drug market and surgical treatment, include diets and diet books, exercise alone or with supervision in exercise facilities, dietary supplements, group programs, doctors, ...

Chopsticks are popular dining utensils in many Asian countries. It is well recognized that the pincers-pinching mode has been recommended for chopsticks operation for Chinese dining. The objective of this study was to propose an auxiliary device for transferring the subjects who had experienced scissors pinching to that of pincers ...

BACKGROUND: Self-poisoning with pesticides is the cause of an estimated 300,000 deaths annually in rural Asia. The great majority of these deaths are from impulsive acts of self-harm using pesticides that are readily available in the home. The secure storage of pesticides under lock has been emphasized as a possible ...

BACKGROUND AND AIMS: Colonoscopy is an excellent but imperfect modality for colorectal cancer screening and prevention. We studied the effects of a retractable transparent extension device on adenoma detection rate as well as on intubation and withdrawal times. METHODS: Colonoscopy with or without the transparent retractable extension (TRE) was performed ...

The Publisher regrets that this article is an accidental duplication of an article that has already been published in Food Chem. Toxicol., 46 (2008) 1205, doi:10.1016/j.fct.2007.10.019. The duplicate article has therefore been withdrawn.

The Food and Drug Administration (FDA) has developed a new method for assessing food safety in retail establishments using a risk factor-based approach for prevention of foodborne illness. The study reported here surveyed facilities in the Navy's San Diego jurisdiction (11 fast-food and 22 full-service facilities) to establish a baseline ...

This paper reviews the history of the federal regulatory oversight of plant agricultural biotechnology in the USA, focusing on the scientific and political forces moulding the continually evolving regulatory structure in place today. Unlike most other jurisdictions, the USA decided to adapt pre-existing legislation to encompass products of biotechnology. In ...

The U.S. Food and Drug Administration (FDA) should reevaluate its position on aspartame as being safe under all conditions. Animal bioassay results predict human cancer risks, and a recent animal study confirms that there is a potential aspartame risk to humans. Aspartame is produced and packaged in China for domestic ...

Vacuum impregnation (VI) is a food processing method by which air and native solution are removed from porous spaces within a food and replaced by an external solution. In this study, an experimental device based on a previous design was built, including some modifications, in order to investigate the dynamics ...

A taxometric analysis of the Psychopathy Checklist-Revised (PCL-R) is conducted on a group of 409 male maximum-, medium-, and minimum-security federal prison inmates using the four PCL-R facet scores (interpersonal, affective, impulsive lifestyle, and antisocial behavior) as indicators. Results obtained from three quasi-independent taxometric procedures-mean above minus below a cut, ...

Different methods for construction of contactless conductivity detectors (CCD) for microchip electrophoresis device are described in this review. This includes three main schemes of CCD for microchips, such as (i) the detection electrodes are placed along the microchannel from outside of the microchip and they are insulated from the channel ...

The Food and Drug Administration (FDA) is issuing an interim final rule (IFR) that sets forth a procedure for requesting an exemption from the requirement in the final rule "Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements," published elsewhere in this issue of the ...

Heparin-induced thrombocytopenia (HIT) is an immune-mediated complication that can occur after exposure to heparin products. Because patients with HIT are at increased risk for thrombosis, anticoagulation is warranted. The direct thrombin inhibitors lepirudin and argatroban are approved by the United States Food and Drug Administration (FDA) for this indication. Bivalirudin, ...

The Food and Drug Administration (FDA) is classifying the computerized labor monitoring systems into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Computerized Labor ...

The Food and Drug Administration (FDA) is issuing a final rule establishing that over-the-counter (OTC) laxative drug products in granular dosage form containing the bulk-forming psyllium ingredients (psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), psyllium seed husks, plantago ovata husks, and plantago seed) are not generally recognized ...

Aptamers are single stranded DNA or RNA ligands which can be selected for different targets starting from a huge library of molecules containing randomly created sequences. Aptamers have been selected to bind very different targets, from proteins to small organic dyes. In addition to the very important aspect of having ...

Various types of semi-adjustable articulators (arcon and nonarcon), in combination with different interocclusal recording materials (wax and polyether), have been proposed as an easier alternative to extraoral tracing devices or axiographs. There is no consensus as to which combination is the nearest to the recognized standard extraoral tracing devices. This ...

Two types of solid-phase materials, a styrenedivinylbenzene copolymer sorbent (embedded in a SDB-XC Empore disk) and a styrenedivinylbenzene copolymer sorbent modified with sulfonic acid functional groups (embedded in a SDB-RPS Empore disk), were compared as a receiving phase in a passive sampling device for monitoring polar pesticides. The SDB-XC Empore ...

This paper presents information about U.S. Food and Drug Administration (FDA) considerations for intrauterine progestins as part of a hormone replacement therapy strategy. Current U.S.-approved intrauterine systems are reviewed as well as FDA formal guidance to industry regarding clinical evaluation of combination hormone products. The formal guidance is contrasted with ...

BACKGROUND: Evidence suggests that attendance at medical grand rounds at academic medical centers is waning. The present study examined whether attendance at medical grand rounds increased after providing complimentary food to attendees and also assessed attendee attitudes about complimentary food. METHODS: In this prospective, before-and-after study, attendance at medical grand ...

We tested reproducibility of exhaled nitric oxide (FE(NO)) and inter-operator handling when measured with a handheld device, NIOX MINO. We enrolled 20 volunteers using a priori goals of acceptable reproducibility to be mean within-subject standard deviation less than 3 parts per billion (ppb) for FE(NO) measurements less than 30 ppb, ...

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 ...

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 ...

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 ...

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 ...

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 ...

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) ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...