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Results for “Device Approval”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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At least 1,279 records · Page 71Linked to original sources
PubMed2006

Transient elastography (FibroScan) for non-invasive assessment of liver fibrosis.

(1) Liver fibrosis is associated with significant morbidity and mortality. The major cause is hepatitis C, which affects 240,000 Canadians. (2) Assessing the degree of liver fibrosis is critical to its management. Liver biopsy, an invasive procedure, is considered to be the diagnostic gold standard. (3) FibroScan is a rapid, non-invasive technology that uses low frequency vibration and ultrasound to assess the stiffness of liver tissue. (4) The diagnostic performance of FibroScan is good for identifying severe fibrosis or cirrhosis, but it is less accurate for milder presentations. (5) FibroScan is a promising technology, but large multi-centre trials comparing a range of emerging non-invasive fibrosis staging technologies are required.

Biopsy↗
PubMed2006

Digital mammography: an update.

(1) Digital mammography can improve breast-image quality and storage through the digital capture of x-ray images. (2) Large comparative studies indicate that the overall accuracy of full-field digital mammography (FFDM) is similar to that of conventional filmscreen mammography (FSM). (3) Recent evidence suggests that FFDM is more accurate than FSM for diagnosing cancer in women younger than 50 years, those with dense breasts, and pre- or peri-menopausal women. (4) The costs of FFDM are higher than those for FSM. (5) The quality control of FFDM systems offers advantages compared to that of FSM, but it is more complex, and it is associated with a long learning curve.

Breast Neoplasms↗
PubMed2006

Open magnetic resonance imaging (MRI) scanners.

(1) In most MRI scanners, the patient examination table fits inside a long cylindrical tube. Large patients cannot be accommodated, and some persons experience claustrophobic reactions. Open MRI systems, in which the patient is placed between two plates, overcome these disadvantages. (2) Open MRI scanners are widely used in health care. High-field closed MRI systems are preferred for many examinations. (3) Early versions of open MRI scanners had low magnetic field strength, gave poorer image quality than most closed systems, and required longer examination times. Newer open scanners include machines with higher magnetic field strengths and improved image quality. (4) Closed high magnetic field scanners with short magnets and wide bore tubes offer improved comfort to patients, and may be an alternative to open scanners. (5) There is interest in using open systems for intra-operative and image-guided interventions.

Canada↗
PubMed2006

Hot techniques for tonsillectomy.

(1) Some patients experience pain and bleeding after a standard or extracapsular tonsillectomy. (2) Evidence suggests that none of the hot tonsillectomy techniques offers concurrent reductions in intra- and post-operative bleeding and pain, compared with traditional cold-steel dissection with packs or ties. (3) Little information is available on the cost effectiveness of the hot techniques. (4) Diathermy is likely to remain the most commonly practised hot tonsillectomy technique.

Adenoidectomy↗
PubMed2006

Intra-articular hyaluronic acid (viscosupplementation) for knee osteoarthritis.

(1) In viscosupplementation, a glycosaminoglycan (GAG) called hyaluronic acid (HA) is administered via intra-articular (IA) injection for patients with knee osteoarthritis (OA). (2) Evidence suggests modest short-term reductions in pain and improvements in function, and no superiority among HA products. (3) Adverse events are rare, benign, temporary, and likely associated with the IA injection. (4) Economic analyses of mixed quality suggest that HA may be cost effective compared with usual care. (5) Clinical practice guidelines and evidence suggest that this approach is most suitable for patients with mild to moderate knee OA, and in those for whom other approaches are contraindicated, or have failed.

Canada↗
PubMed2006

Insertion procedure, aftercare, and soft-tissue reaction of the 2.5-mm titanium tube system for a transcutaneous air conduction hearing aid system.

The term transcutaneous air conduction hearing aid system designates a new category of hearing devices established by the U.S Food and Drug Administration in 2002. The only product included in this category is the RetroX device manufactured by Auric Hearing Systems, Rheine, Germany. This device consists of two components: a titanium tube system for sound conduction and a hearing processor. The component implanted in the soft tissue of the outer ear is the titanium tube system, for which the outer diameter of the central part has recently been reduced. Both the implantation tools and the tube system itself have been optimized over the last few years with regard to shape and function, thus effectively reducing the surgery involved to a kind of "functional body piercing" procedure. As a result of this, the time required for implantation has been minimized, as has the duration and severity of postoperative soft-tissue reaction. Complications may be avoided by correct positioning and proper mounting of the tube system in the outer ear, comprehensive patient counseling, and scheduled aftercare. One key objective is to ensure that the soft-tissue channel in which the titanium tube is implanted heals without any inflammatory reaction.

Device Approval↗
PubMed2006

Managing clinical data for worldwide acceptance.

Manufacturers conducting clinical studies to support medical device safety and performance claims need to ensure that clinical study data are appropriately managed. Not doing so can risk the success of the project related to the clinical study. This article discusses a guideline that can assist in this effort.

Clinical Trials as Topic↗
PubMed2006

[An exploratory discussion on biological evaluation and risks for medical devices].

Biological evaluation of medical devices before clinical usage has become one of the necessary procedure. But many of medical devices which have already passed a series of biological safety evaluation do not mean that they are absolutely safe and harmless. And there are still application risks in these medical devices, because of the deficient knowledge about the interaction of biomedical materials and human tissue, limitation of the existent technology level, the indefiniteness of the evaluation system, the imperfections of present standards and so on. This essay is trying to analyze the relationship between the biological evaluation of medical devices and their application risks, and to discuss how to make a risk analysis related to biological evaluation in order to acquire a better and exact understanding of biological evaluation for medical devices.

Device Approval↗
PubMed2006

Photoselective vaporization for benign prostatic hyperplasia.

(1) In photoselective vaporization of the prostate (PVP) for benign prostatic hyperplasia (BPH), laser energy is used to vaporize prostatic tissue rapidly and bloodlessly. (2) Studies suggest that PVP performs well in the short term. (3) Randomized controlled trials (RCTs) and longterm follow-up are required to determine PVP's place in the management of BPH.

Aged↗
PubMed1989

Cochlear implant indications.

Many centers are investigating the safety and efficacy of cochlear implants in adults and children. In the United States, the Food and Drug Administration (FDA) has monitored these investigations, recently approving two devices for general use in adults. In general, appropriate implant candidates have a bilateral, profound to total sensorineural hearing loss, are unable to benefit from conventional hearing aids, are in good physical and mental health, and have the motivation and patience to complete a rehabilitation program. The patient likely to receive most benefit from a cochlear implant is one who acquires profound deafness after developing verbal language skills and is implanted within a few years of the onset of deafness.

Cochlear Implants↗