Center for Medical Device Evaluation

Beijing, China

Center for Medical Device Evaluation

Beijing, China
SEARCH FILTERS
Time filter
Source Type

Wang R.,Peking University | Wang J.,Center for Medical Device Evaluation | Gao G.,Peking University | Hu J.,Peking University | And 5 more authors.
Clinical Cancer Research | Year: 2017

Purpose: To investigate whether prebiopsy multi-parametric (mp) MRI can help to improve predictive performance in prostate cancer. Experimental Design: Based on a support vector machine (SVM) analysis, we prospectively modeled clinical data (age, PSA, digital rectal examination, transrectal ultrasound, PSA density, and prostate volume) and mp-MRI findings [Prostate Imaging and Reporting and Data System (PI-RADS) score and tumor–node–metastasis stage] in 985 men to predict the risk of prostate cancer. The new nomogram was validated in 493 patients treated at the same institution. Multivariable Cox regression analyses assessed the association between input variables and risk of prostate cancer, and area under the receiver operating characteristic curve (Az) analyzed the predictive ability. Results: At 5-year follow-up period, 34.3% of patients had systemic progression of prostate cancer. Nomogram (SVM-MRI) predicting 5-year prostate cancer rate trained with clinical and mp-MRI data was accurate and discriminating with an externally validated Az of 0.938, positive predictive value (PPV) of 77.4%, and negative predictive value of 91.5%. The improvement was significant (P < 0.001) compared with the nomogram trained with clinical data. When stratified by PSA, SVM-MRI nomogram had high PPV (93.6%) in patients with PSA > 20 ng/mL, with intermediate to low PPV in PSA 10 to 20 ng/mL (64%), PSA 4 to 10 ng/mL (55.8%), and PSA 0 to 4 ng/mL (29%). PI-RADS score (Cox HR, 2.112; P < 0.001), PSA level (HR, 1.435; P < 0.001), and age (HR, 1.012; P ¼ 0.043) were independent predictors of prostate cancer. Conclusions: Featured with low false positive rate, mp-MRI could be the first investigation of a man with a raised PSA before prostate biopsy. ©2017 AACR.


Dong J.-C.,Center for Medical Device Evaluation
Chinese Journal of Pharmaceutical Biotechnology | Year: 2016

As more and more viral nucleic acid detection reagents were developed and applied, the registration process of these novel reagents is attracting more and more attention. Performance evaluation and clinical test have always been considered as the pivotal steps in the process of reagents registration. In this review, the major point, standard operation and related technical details were summarized so as to guide manufacturers to research and to develop nucleic acid reagents scientifically and rationally. © 2016, Editorial Board of Pharmaceutical Biotechnology. All right reserved.


Zhao P.,Center for Medical Device Evaluation
Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery | Year: 2012

To review the registration and technical data for breast implants. Recent literature concerning registration for breast implants was reviewed and analyzed. The aspects on registration for breast implants are complicated. The major aspects include providing technical data, establishing develop standard, progress type test, and developing the registration specification. The manufacturers need to be well aware of the risk of this kind of product and have the full ability to conduct the researching and developing. Only the strict risk controlling can ensure the safety and effectiveness of the product.


Zhang Z.,Center for Medical Device Evaluation
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2012

Recent years, China medical devices industry has been a sunrise industry with widely-ranged products, high-tech innovation, and booming market demands. But with the globalization of market economy, China industry is still in the inferior position of competition. How to promote the industrial structure transition, increase scientific and technological level, speed up the updating of products, enhance the international competitiveness is one of the major tasks to maintain the healthy development of industry. This article makes a study on current situation of China medical devices industry, analyses the new opportunities, challenges and restriction factors, provides the countermeasures of strengthening industry competitiveness as well.


Xu X.,Guangzhou University | Tao A.,Guangzhou University | Xu Y.,Guangzhou University | Xu Y.,Center for Medical Device Evaluation
Nanoscale | Year: 2014

Hydrogels are a promising class of biomaterials that can be easily tailored to produce a native extracellular matrix that exhibits desirable mechanical and chemical properties. Here we report the construction of a hydrogel via the assembly of cucumber mosaic virus (CMV) capsid protein and Y-shaped and cross-shaped DNAs. This journal is © The Royal Society of Chemistry.


Zhao P.,Center for Medical Device Evaluation
Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery | Year: 2012

To review the registration and technical data for sodium hyaluronate facial derma fillers. Recent literature concerning registration for sodium hyaluronate facial derma fillers was reviewed and analyzed. The aspects on registration for sodium hyaluronate facial derma fillers include nominating the product, dividing registration unit, filling in a registration application form, preparing the technical data, developing the standard, and developing a registration specification. The main difficulty in registration is how to prepare the research data of that product, so the manufacturers need to enhance their basic research ability and work out a scientific technique routing which could ensure the safety and effectiveness of the product, also help to set up the supportive documents to medical device registration.


Zhang Y.,Center for Medical Device Evaluation
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2013

Active implantable medical device develops rapidly in recent years. The clinical demands and current application are introduced, the technical trends are discussed, and the safety risks are analyzed in this paper.


Guo Z.,Center for Medical Device Evaluation
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2012

This article introduces the clinical requests of indigenous diagnostic imaging ultrasound devices in first-time registration application and the clinical trial requests in Technical Review Guidance of Ultrasound Imaging Diagnostic Devices (category III) Registration and puts forward some questions of the guidance's implementation. It is hoped to help concerned people.


Lu Y.-F.,Center for Medical Device Evaluation
Yaoxue Xuebao | Year: 2013

Using brain microdialysis and LC-ECD, the content of dopamine in rat brain was detected to investigate the effects of ligustrazine. A liquid chromatography-electrochemical detector method has been established and validated for the determination of dopamine in rat brain dialysate. The results indicate that ligustrazine administration by subcutaneous injection significantly increased dopamine release in rat medial prefrontal cortex, nucleus accumbens and hippocampus in a dose-related manner. The drug's effects on dopa release in rat brain could be directly detected by microdialysis combined with HPLC-ECD and this method has the preponderance over traditional neurology methods.


Zhang Y.,Center for Medical Device Evaluation
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2013

Deep brain stimulation (DBS) therapy develops rapidly in clinical application. The structures of deep brain stimulator and magnetic resonance imaging (MRI) equipment are introduced, the interactions are analyzed, and the two compatible problems of radio frequency (RF) heating and imaging artifact are summarized in this paper.

Loading Center for Medical Device Evaluation collaborators
Loading Center for Medical Device Evaluation collaborators