Search PubMed⌕ Search

SEARCH · Search PubMed

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.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 1,207 records · Page 67Linked to original sources
PubMed2005

Mobile-bearing knee systems: ultra-high molecular weight polyethylene wear and design issues.

In June 2004, the U.S. Food and Drug Administration Orthopaedic Advisory Panel recommended the reclassification of mobile-bearing knee systems for general use. This reflects the increasing use of mobile-bearing knee systems internationally, which is currently limited in the United States by regulatory requirement. Mobile-bearing knee systems are distinguished from conventional, fixed-plateau systems in that they allow dual-surface articulation between an ultra-high molecular weight polyethylene insert and metallic femoral and tibial tray components. Their in vivo success is dependent on patient selection, design, and material choice, as well as surgical precision during implantation. Laboratory and clinical experience extending over 25 years with individual systems suggests that mobile-bearing knee systems represent a viable treatment option for patients with knee arthrosis.

Arthroplasty, Replacement, Knee↗
PubMed2001

The Center for Devices and Radiological health: an update.

At a recent medical device conference, Dr. David Feigal, the Director of the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) stated that one-third of the CDRH staff will retire in five years. This is only one of many challenges that the Center faces.This article discusses key factors shaping current FDA device policies and programmes, the CDRH strategic plan, the continuing importance of the standards programme, and CDRH harmonisation activities.

Device Approval↗
PubMed2005

The current state of in-vivo pre-clinical animal models for heart valve evaluation.

For over 30 years, animal models have remained a central critical component in the pre-clinical safety evaluation of prosthetic heart valves developed for use in humans. Though many advances have been made in valve design, no ideal replacement prosthesis has yet been developed. As a result, valve manufacturers continue to address issues relating to thrombogenicity, structural integrity, fluid dynamics and calcification in their designs. Many animal models have been developed to examine these issues, including dog, pig, calf and sheep, yet no standard model has been accepted. Recently, the International Standard Organization has provided guidelines in document 5840 to address cardiovascular implants. The aim of this report is to provide a summary of the current state of pre-clinical valve evaluation in animals. Changes in ISO 5840 will be addressed that have occurred between 1998 and the present date, and the role of current available animal models. The aim also is to provide rational guidance in the selection of appropriate animal models to match the purpose of valve implantation studies.

Animals↗
PubMed2005

New trends in biological evaluation of medical devices.

More extensive material characterisation and increased determination of toxicological risks are now required when evaluating new medical devices. The new requirements together with other changes in the ISO 10993 series described here suggest how companies can adjust their approach.

Consumer Product Safety↗
PubMed2005

US importer and distributor requirements.

A medical device manufacturer who exports products to the United States (US) may risk success in this activity by not being aware of US importer and distributor requirements. This article discusses the requirements and actions that nonUS manufacturers should take to ensure these requirements are met.

Commerce↗
PubMed2005

MRI-guided focused ultrasound treatment of uterine fibroids.

Magnetic resonance imaging-guided focused ultrasound (MRI-FUS) is a minimally invasive alternative to surgical and less invasive treatments for uterine fibroids. Early results from small sample studies indicate that the procedure may provide short-term symptom relief with advantages such as shorter recovery time. Few occurrences of major adverse events are reported. Little information is available on the costs or comparisons with other treatments. Long-term studies of larger patient groups are needed to provide further reliable evidence on the safety of this procedure, as well as its clinical and cost-effectiveness.

Catheter Ablation↗
PubMed2005

[Studies on administration of in-vitro diagnostic reagents].

This article introduces the definition, classification, premarket admission and other administering specialities about In-Vitro Diagnostic Reagents in the U.S.A. and China. And by analyzing manufacture and administration of In-Vitro Diagnostic Reagents in our country, It is pointed out that a suitable administering model in accordance with the characteristics of In-Vitro Diagnostic Reagents should be adopted to perfect the administration.

China↗
PubMed2005

Performance evaluation of the Sysmex pocH-100i automated hematology analyzer.

The Sysmex pocH-100i automated hematology analyzer was evaluated at St. John's Regional Health Center, Springfield, Missouri, USA, and compared with the Sysmex KX-21N. The pocH-100i is a compact, fully automated hematology analyzer with the capability for simultaneous analysis of 17 parameters in the whole-blood mode. The touch screen liquid crystal display presents results, and the 3 histograms for white blood cell (WBC), red blood cell (RBC), and platelet (PLT) counts can be printed along with numerical results. This study was performed to provide necessary information for the US Food and Drug Administration study of allowing the product's use in the North American marketplace. The pocH-100i processes approximately 25 samples/hour, uses 2 reagents, and provides for testing in a closed-tube environment, while using only 15 microL in the whole-blood mode and 20 microL in the predilute mode. Using hydrodynamic focusing on the pocH-100i improves the accuracy for RBC and PLT measurements. Our evaluation included studies of correlation, carryover, reproducibility, linearity, and stability. Results with the pocH-100i showed good correlation with those from the KX-21N for the following parameters: WBC; numbers and percentages of lymphocytes, mixed cells (monocytes, eosinophils, and basophils), and neutrophils; RBC; hemoglobin; hematocrit; mean corpuscular volume; mean corpuscular hemoglobin; mean corpuscular hemoglobin concentration; PLT; red cell distribution width SD (RDW-SD); RDW coefficient of variation; and mean platelet volume. Carryover and reproducibility were well within the manufacturer's specifications. The pocH-100i showed linearity over the entire range for all parameters studied. A reference range for a healthy population was also established. We conclude that the overall performance of the pocH-100i is excellent and compares favorably with that of the KX-21N.

Blood Cell Count↗