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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 1,009 records · Page 56Linked to original sources
PubMed2002

Extracorporeal immunoadsorption treatment for rheumatoid arthritis.

Immunoadsorption treatment is a non-drug therapy for rheumatoid arthritis. The treatment is based on filtering the patient's plasma through a column containing staphylococcal protein A. The treatment is effective in alleviating the symptoms of severe rheumatoid arthritis in some patients. Data on long-term outcomes are not available. The mechanism of action of this treatment is unclear. Most adverse effects are associated with the apheresis procedure. The cost per 12 week course of treatment is likely to be more than C $20,000. The cost-effectiveness of the technology is not yet established.

Arthritis, Rheumatoid↗
PubMed2002

Computer-enhanced surgical systems ("robotic surgery").

Computer-linked surgical systems allow surgeons to perform procedures without coming into contact with the patient. Indications for these robotic surgery systems are expanding. This technology offers potential advantages through enabling more precise surgery, which may lead to shorter patient recovery times, fewer complications and improved patient outcomes. Limited studies indicate the promise of these systems, which appear to be safe, but their efficacy is not fully established. In some procedures, the advantages they offer may also be achieved by newer non-computer assisted techniques. Capital costs are high and cost-effectiveness has not been demonstrated. Diffusion of these systems can be expected to continue, but their place in surgical practice is not yet clear. They are most likely to be of value for centres undertaking specialized surgical services.

Canada↗
PubMed2002

Postmarket surveillance. Final rule.

The Food and Drug Administration (FDA) is implementing the postmarket surveillance (PS) provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The purpose of this rule is to provide for the collection of useful data about devices that can reveal unforeseen adverse events or other information necessary to protect the public health.

Consumer Product Safety↗
PubMed2002

Clinical investigations and clinical evaluation strategies.

It is accepted that no device that is clinically effective is entirely without hazard, and not all hazards can be known before a device is marketed. This article outlines the strategies to adopt when evaluating the benefit-risk ratios of high-risk medical devices.

Device Approval↗
PubMed2002

Continuous glucose monitoring in the management of diabetes mellitus.

Continuous glucose monitors (CGMs) measure interstitial fluid (ISF) glucose, and provide information about continuous glucose fluctuations that is not otherwise captured by intermittent blood glucose testing. CGMs may benefit patients having difficulty controlling their blood sugar or during initiation or monitoring of insulin pump use. CGMs require calibration with finger-stick tests and supplement, but do not replace conventional blood glucose testing. CGM values correspond to blood glucose values taken approximately 13-18 minutes earlier and may differ from metered readings.

Blood Glucose↗
PubMed2002

Biological evaluation as part of risk assessment.

This overview of how to conduct a risk assessment highlights the use of one of the newest standards in this area ISO 14971, which covers the application of risk management, as well as ISO 10993, which covers biological evaluation of medical devices. A hypothetical risk evaluation of a device is also described.

Animals↗
PubMed2002

Implementation of the medical device directives in Italy.

Medical device manufacturers marketing their products in Italy, or planning to do so, need to be aware of any national requirements such as those concerning the registration of manufacturers and devices and language requirements that may apply to their products. This article provides an update on the implementation of the European Directives for medical devices in Italy.

Biomedical Engineering↗
PubMed2002

Medical devices; apnea monitor; special controls. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule to create a separate classification for the apnea monitor. The device currently is included in the generic type of device called breathing frequency monitors. The apnea monitor will remain in class II, but will be subject to a special control. The special control is an FDA guidance document that identifies minimum performance, testing, and labeling recommendations for the device. Following the effective date of this final classification rule, any firm submitting a 510(k) premarket notification for a "new" apnea monitor will need to address the issues covered in the special control guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control. FDA is taking these actions because it believes that they are necessary to provide reasonable assurance of the safety and effectiveness of the apnea monitor.

Apnea↗
PubMed2002

Medical devices; reclassification of polymethylmethacrylate (PMMA) bone cement. Final rule.

The Food and Drug Administration (FDA) is announcing that it has reclassified the polymethylmethacrylate (PMMA) bone cement intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone from class III to class II (special controls). The agency is also announcing that it has issued an order in the form of a letter to the Orthopedic Surgical Manufacturers Association (OSMA) reclassifying the device. The special control for the device is a guidance document entitled "Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement." The agency is reclassifying this device into class II because special controls, in addition to general controls, would provide reasonable assurance of the safety and effectiveness of the device, and there is sufficient information to establish special controls.

Bone Cements↗
PubMed2002

Using a spectral reflectance technique to measure transcutaneous bilirubin in neonates: a new device.

Devices that use a spectral reflectance technique are used to non-invasively measure total bilirubin levels in neonates to monitor the development of hyperbilirubinemia. As a screening technique for the healthy neonate population, these devices provide instantaneous information, may reduce the need of heel-pricks on neonates, and indicate which neonates will need serum bilirubin measurement. Evidence from studies supported by the manufacturer of BiliChek (tm), the newest device using the spectral reflectance technique, suggests that there is a linear correlation between transcutaneous bilirubin measured by BiliChek (tm) and total serum bilirubin as measured by the gold standard technique (i.e. HPLC). The correlation, however, is limited by gestational age of the neonate, as well as certain pathological neonatal conditions. Prospective cohort studies on the effectiveness of the technology in the reduction of hospital readmission, and using the incidence of morbidity and mortality from kernicterus as clinical endpoints, would be useful.

Bilirubin↗