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Results for “Device Approval”

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At least 1,153 records · Page 64Linked to original sources
PubMed2004

[Electroconvulsive therapy: past, present, and future].

Although electroconvulsive therapy (ECT) was first introduced to treat schizophrenia in 1938, it is widely used for the treatment of various major psychiatric disorders, including depression. In western countries, its safety has been improved with the introduction of techniques such as succinylcholine muscle relaxation, barbiturate anesthesia, oxygenation and brief-pulse stimulation. Although the first use of ECT in Japan was reported in 1939, few modifications of the ECT technique have been made since then. From the 1980s, in collaboration with anesthesiologists, ECT with anesthesia and muscle relaxation (modified ECT) has been administered in numerous general hospitals. Moreover, brief-pulse ECT devices were approved in 2002. Rapid progress in ECT practices is expected in Japan. Before administering ECT, informed consent should be obtained from the patient, except when the patient lacks capacity to consent. The major problems in ECT are cognitive side effects and high relapse rates. Furthermore, its mechanisms of action are still unknown. These problems must be solved in the near future.

Electroconvulsive Therapy↗
PubMed2004

Beyond the US submisson process.

After expending considerable effort to comply with United States (US) marketing authorisation regulations, a company launched its first product on the US market. Unfortunately, the company failed to comply with other applicable US regulations, which led to a delay in the US product introduction and FDA postmarketing enforcement actions against the product. This article discusses ways that companies can prevent this from happening.

Commerce↗
PubMed2004

The critical path to medical innovation.

In the United States,the Food and Drug Administration (FDA) and the National Institutes of Health have noted a significant decrease in the number of innovative products reaching patients, in spite of a rapidly expanding basis of fundamental scientific knowledge. A recent FDA report proposes some solutions to this problem.

Clinical Trials as Topic↗
PubMed2004

Effective risk management programmes.

Far too many medical device companies are failing to reap the benefits of an effective risk management programme. Thus, patients, users and the companies themselves are continuing to suffer the consequences of device problems that could have been identified and resolved before products are placed on the market. This article discusses how to implement an effective programme.

Device Approval↗
PubMed2004

Evidence-based medicine and drug-eluting stents.

Successful implementation of evidence-based medicine in the development of high-risk medical devices requires a methodical scientific approach. However, even when research evidence is available from randomised controlled studies, it can be difficult to translate clinical evidence into regulatory and clinical decisions. Drug-eluting stents are used as an example to illustrate this principle.

Clinical Trials as Topic↗
PubMed2004

Minimally invasive total hip replacement.

Total hip replacement (arthroplasty) is a widely used procedure that alleviates pain and disability in people with hip disorders, such as osteoarthritis. Minimally invasive (MI) total hip replacement uses a smaller surgical incision than the conventional method. Possible advantages include less damage to tissue and muscle, smaller scars, less blood loss during surgery, less postoperative pain and shorter hospital stays and convalescence. Well designed, long-term studies are needed to compare patient outcomes and costs of the different types of MI hip replacement procedures.

Arthroplasty, Replacement, Hip↗
PubMed2004

Dental devices; dental noble metal alloys and dental base metal alloys; designation of special controls. Final rule.

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 this action on its own initiative. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance documents that would serve as special controls for these devices.

Alloys↗
PubMed2004

[Biologically active food supplements. Report 1].

In article we would like to remind once of what each of the food supplement consumer should know. Food supplement is not a medicine, you can treat no illness with it. But at the same time we should understand, that it is impossible to live without them, as well as it impossible to live without food or the air. It is important to deepen one's knowledge of food supplements: what they consist of, which of them are health-giving and which are not.

Deficiency Diseases↗
PubMed2004

Medical devices; immunology and microbiology devices; classification of the beta-glucan serological assay. Final rule.

The Food and Drug Administration (FDA) is classifying the beta-glucan serological reagent device 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: Serological Assays for the Detection of Beta-Glucan." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

Antigens, Fungal↗