Results 1 to 10 of about 1,823,738 (182)

Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance.

Journal of the American Medical Association (JAMA), 2023
Importance Most regulated medical devices enter the US market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are "substantially equivalent" to 1 or more "predicate" devices (legally marketed medical
Alexander O Everhart, S. Sen, A. Stern, Yi Zhu, P. Karaca-Mandic   +4 more
semanticscholar   +1 more source

Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration's 510(k) Pathway and Risk of Subsequent Recalls.

Journal of the American Medical Association (JAMA), 2023
Importance In the US, nearly all medical devices progress to market under the 510(k) pathway, which uses previously authorized devices (predicates) to support new authorizations.
Kushal T Kadakia, Sanket S. Dhruva, C. Caraballo, J. Ross, H. Krumholz   +4 more
semanticscholar   +1 more source

Clinical characteristics, activity levels and mental health problems in children with long coronavirus disease: a survey of 510 children

Future Microbiology, 2022
Background: Whether long coronavirus disease pertains to children as well is not yet clear. Methods: The authors performed a survey in children suffering from persistent symptoms since initial infection.
D. Buonsenso, Ferran Espuny Pujol, D. Munblit, D. Pata, Sammie McFarland, Frances K Simpson   +5 more
semanticscholar   +1 more source

The 510(k) Third Party Review Program: Promise and Potential

Journal of medical systems, 2023
Every year, the Food and Drug Administration (FDA) clears approximately 3,000 medical devices for marketing via the 510(k) pathway. These constitute 99% of all devices approved for human use and includes the premarket review of many devices incorporating
Brian Miller, William Blanks, Brian F. Yagi   +2 more
semanticscholar   +1 more source

Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017

JAMA Network Open, 2021
Key Points Question What is the risk of recall and high-risk recall for devices undergoing US Food and Drug Administration (FDA) 510(k) clearance compared with premarket approval (PMA)? Findings In this cohort study using the FDA’s 510(k) and PMA medical
Jonathan R Dubin, S. Simon, Kirsten Norrell, Jacob Perera, Jacob Gowen, A. Cil   +5 more
semanticscholar   +1 more source

Novel circular RNA circSLIT2 facilitates the aerobic glycolysis of pancreatic ductal adenocarcinoma via miR-510-5p/c-Myc/LDHA axis

Cell Death and Disease, 2021
Increasing evidence has indicated the great diagnostic and therapeutic potentials of circular RNAs (circRNAs) in human cancers. Although the biological roles of circRNAs in pancreatic ductal adenocarcinoma (PDAC) have been partially annotated, the ...
H. Guan, W. Luo, Yuping Liu, Mingfei Li
semanticscholar   +1 more source

Clinical Characteristics, Activity Levels and Mental Health Problems in Children with Long COVID: A Survey of 510 Children

, 2021
Background The World Health Organization has recently recognized Long COVID, calling the international medical community to strengthen research and comprehensive care of patients with this condition. However, if Long COVID pertains to children as well is
D. Buonsenso, F. Espuny Pujol, D. Munblit, S. McFarland, Frances K Simpson   +4 more
semanticscholar   +1 more source

Supplementation with Lactiplantibacillus plantarum IMC 510 Modifies Microbiota Composition and Prevents Body Weight Gain Induced by Cafeteria Diet in Rats

International Journal of Molecular Sciences, 2021
Changes in functionality and composition of gut microbiota (GM) have been associated and may contribute to the development and maintenance of obesity and related diseases.
M. V. Micioni Di Bonaventura, M. Coman, D. Tomassoni, E. Micioni Di Bonaventura, L. Botticelli, M. G. Gabrielli, G. Rossolini, V. di Pilato, C. Cecchini, A. Amedei, S. Silvi, M. Verdenelli, C. Cifani   +12 more
semanticscholar   +1 more source

The value of miR-510 in the prognosis and development of colon cancer

Open Medicine, 2021
Purpose Colon cancer is one of the malignant tumors that threatens human health. miR-510 was demonstrated to play roles in the progression of various cancers; its dysregulation was speculated to be associated with the development of colon cancer. Methods
Junjie Hang, Feifei Wei, Zhiying Yan, Xianming Zhang, Kequn xu, Ying-wei Zhu   +5 more
semanticscholar   +1 more source

Ovarian reserve parameters and IVF outcomes in 510 women with poor ovarian response (POR) treated with intraovarian injection of autologous platelet rich plasma (PRP)

Aging, 2020
The aim of the current study was to characterize ovarian reserve parameters and IVF outcomes in women with a history of poor ovarian response (POR) treated with intraovarian injection of autologous platelet rich plasma (PRP).
Y. Çakıroğlu, Aysen Yuceturk, Ozge Karaosmanoglu, Sule Yildirim Kopuk, Zeynep Ece Utkan Korun, N. Herlihy, R. Scott, B. Tiras, E. Seli   +8 more
semanticscholar   +1 more source