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Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

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At least 613 records · Page 34Linked to original sources
PubMed2003

FDA regulation of technology and surgical devices in the operating room.

Federal regulation of medical devices began in 1976 with the signing of the Medical Device Amendments to the Food, Drug and Cosmetic Act. For the purpose of regulating medical devices, the Food and Drug Administration is divided into various divisions and branches, including the Office of Device Evaluation. The evolution of the Food and Drug Administration's regulations of laparoscopic devices is described. Also described is the technology of laparoscopic surgical devices and how they are regulated by the Office of Device Evaluation. Trends towards the future of laparoscopic devices, and their regulation, are reviewed.

Biomedical Technology↗
PubMed2002

The utility of ductal lavage in breast cancer detection and risk assessment.

Ductal lavage (DL) permits noninvasive retrieval of epithelial cells from the breast. Clinical development of this technique has been fueled largely by its potential, as yet unproven, to improve detection of breast cancer and definition of individual risk for development of breast cancer. Early studies demonstrate the feasibility of performing this technique, provide data on cellular yield and findings, and demonstrate the ability to measure molecular markers in DL fluid. However, the sensitivity and specificity of DL for the detection of breast cancer remains unknown, as does the significance of atypia, particularly mild atypia, when found in DL fluid. Although DL appears safe and the device is approved by the US Food and Drug Administration, DL is still best utilized in the setting of clinical trials designed to resolve issues of sensitivity, specificity, and localization.

Breast↗
PubMed2000

Preclinical assessments of european union marketing authorisation applications for immunomodulatory biopharmaceuticals.

A review of preclinical assessment reports on immunomodulatory biopharmaceuticals submitted to the European Agency for Evaluation of Medicinal Products from 1995 to the middle of 1999 was conducted. Questions regarding the rationale for the preclinical development programmes were often put to the applicants. Effects mediated via changes of the immune function, including risks of reproductive toxicity and tumorigenicity, were of particular concern. This review indicates the need to further develop methods for safety testing of immunomodulatory biopharmaceuticals.

Adjuvants, Immunologic↗
PubMed1994

Electroconvergent cautery.

A new cautery system known as the electroconvergent cautery system is described. This cautery system uses a radiofrequency current of 13.56 MHz. The current is passed through an amplifier, an impedance matching system, and a loading and tuning coil into a probe. After the probe tip is touched to the tissue, the mismatch of impedance between the probe tip and the generator is minimized to almost zero, resulting in high-current density at the probe tip, which causes pinpoint heating of the tissue at the point where it is touched by the probe without spread of heat to the surrounding tissue. This heat can cut and vaporize tissue and coagulate vessels. The probe can also be used to coagulate vessels with standard surgical forceps. Because convergence of energy is used for tissue heating, a grounding pad is not needed. The system can also be used under cerebrospinal fluid or saline.

Astrocytoma↗