Results 81 to 90 of about 333,056 (304)

Voting behavior during FDA Medical Device Advisory Committee panel meetings.

PLoS ONE, 2022
ObjectivesDuring premarket review, the US Food and Drug Administration may ask its Medical Device Advisory Committee (MDAC) Panels to assess the safety and effectiveness of medical devices being considered for approval.
Amanda Maisel-Campbell, Daniel I Schlessinger, Arianna F Yanes, Emir Veledar, Kelly A Reynolds, Sarah A Ibrahim, Bianca Y Kang, Noor Anvery, Emily Poon, Murad Alam   +9 more
doaj   +1 more source

USP29‐regulated noncanonical stabilization of the hypoxia‐inducible factor‐α in aggressive prostate cancer

Molecular Oncology, EarlyView.
We identify USP29 as the only DUB mirroring CA9 expression, a marker of hypoxia and HIF pathway activation associated with PCA aggressiveness. USP29 stabilizes HIF‐1α and HIF‐2α via a noncanonical mechanism that is independent of PHD/pVHL activity yet relies on proteasomal regulation, establishing USP29 as a previously unrecognized regulator of hypoxic
Amelie S Schober, Leire Moreno‐Cugnon, Laura Martínez‐Pérez, Amaia Ercilla, Amaia Zabala‐Letona, Adrián Vicente‐Barrueco, Maider Fagoaga‐Eugui, Saioa Garcia‐Longarte, Blanca Calle‐Ciborro, Encarnación Pérez‐Andrés, Onintza Carlevaris, Sara Pozo, Isabel Mendizabal, Ugo Mayor, Arkaitz Carracedo, Violaine Sée, Edurne Berra   +16 more
wiley   +1 more source

A novel quinazolinone insulin receptor inhibitor and its synergy with an EGFR inhibitor in glucose‐driven glioblastoma

Molecular Oncology, EarlyView.
The novel styrylquinazolinone‐based molecule W1B effectively suppresses glioblastoma by inhibiting IGF1R and EGFR. In high‐glucose microenvironments driving tumor resistance, W1B acts synergistically with the EGFR inhibitor dacomitinib. This combination safely blocks compensatory survival signaling in zebrafish xenograft models. Showcasing promising in
Patryk Rurka, Wioleta Cieślik, Wojciech Płaziński, Katarzyna Stępnik, Anna Boguszewska‐Czubara, Elżbieta Kot, Robert Musioł, Mateusz Jasica, Anna Mrozek‐Wilczkiewicz, Katarzyna Malarz   +9 more
wiley   +1 more source

Comparison of the investigational device exemption and post-approval trials of the Melody transcatheter pulmonary valve

, 2021
OBJECTIVE: We compared 5-year outcomes of transcatheter pulmonary valve (TPV) replacement with the Melody TPV in the post-approval study (PAS) and the investigational device exemption (IDE) trial.
Balzer, David T, Kreutzer, Jacqueline, Cheatham, John P., Jeffrey D. Zampi, Balzer, David T., Robert G. Gray, Thomas K. Jones, Khan, Danyal M, Gray, Robert G., Julie A. Vincent, Hellenbrand, William E, Zampi, Jeffrey D, Khan, Danyal M., Hellenbrand, William E., Bergersen, Lisa J, Zellers, Thomas M, David T. Balzer, Danyal M. Khan, Turner, Daniel R, Moore, John W, McElhinney, Doff B., McElhinney, Doff B, Armstrong, Aimee K., Jones, Thomas K., Allison K. Cabalka, Shicheng Weng, Doff B. McElhinney, Vincent, Julie A, Daniel R. Turner, Javois, Alexander J., Cabalka, Allison K., Thomas M. Zellers, Armstrong, Aimee K, John W. Moore, Weng, Shicheng, Moore, John W., Turner, Daniel R., Bergersen, Lisa J., Rome, Jonathan J, Alexander J. Javois, Cabalka, Allison K, Gray, Robert G, Aimee K. Armstrong, Javois, Alexander J, William E. Hellenbrand, Vincent, Julie A., John P. Cheatham, Rome, Jonathan J., Cheatham, John P, Jacqueline Kreutzer, Zellers, Thomas M., Lisa J. Bergersen, Jonathan J. Rome, Zampi, Jeffrey D., Jones, Thomas K   +54 more
core   +1 more source

Procedure for the approval of a software as a medical device based on a specific example of Humanomed IT Solutions

, 2022
Die Medizinproduktbranche schreitet dynamisch voran. Immer häufiger ist von einer Software als Medizinprodukt die Rede. Die Einführung der neuen europäischen Medizinprodukte Verordnung hat die Thematik noch mehr in den Vordergrund gestellt.
Pluch, Laura
core   +1 more source

PAK1 activation drives divergent resistance mechanisms to aromatase inhibition and tamoxifen in a luminal: A breast cancer model

Molecular Oncology, EarlyView.
Breast cancer remains a major cause of cancer death in women, frequently developing endocrine therapy resistance. This study demonstrates that upregulated p21‐activated kinase 1 (PAK1) activity drives resistance to tamoxifen and long‐term estrogen deprivation in ER+ breast cancer models.
Luisa Schwarzmüller, Janina Müller, Efstathios‐Iason Vlachavas, Lukas Beumers, Lena Fleischhacker, Sara Burmester, Angelika Wörner, Sabine Karolus, Dominic Helm, Cindy Körner, Stefan Wiemann   +10 more
wiley   +1 more source

Proteasomal degradation of intracellularly expressed Amblyomin‐X limits suicide gene therapy potential in melanoma cells

FEBS Open Bio, EarlyView.
This study explores the feasibility of expressing the antitumoral protein Amblyomin‐X through a suicide gene therapy approach and investigates its intracellular fate after gene delivery. Although the gene is efficiently expressed, melanoma cells rapidly degrade the Amblyomin‐X protein via proteasome activity.
Victor Dal Posolo Cinel, Carlos DeOcesano Pereira, Aline Ramos Maia Lobba, Melissa Regina Fessel, Ana Marisa Chudzinski‐Tavassi   +4 more
wiley   +1 more source

Impact of Asymptomatic Intracranial Hemorrhage on Outcome After Endovascular Stroke Treatment

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Background Endovascular treatment (EVT) achieves high rates of recanalization in acute large‐vessel occlusion (LVO) stroke, but functional recovery remains heterogeneous. While symptomatic intracranial hemorrhage (sICH) has been well studied, the prognostic impact of asymptomatic intracranial hemorrhage (aICH) after EVT is less certain ...
Shihai Yang, Chengsong Yue, Zhuang Li, Xiaolei Shi, Haoxuan Zhu, Jie Yang, Linyu Li, Jiaxing Song, Shitao Fan, Gaoming Li, Wenzhe Sun, Zhixian Ye, Jiacheng Huang, Dahong Yang, Jinfu Ma, Xu Xu, Zhixi Wang, Lilan Wang, Guojian Liu, Fengli Li, Changwei Guo, Li Qi, Wenjie Zi   +22 more
wiley   +1 more source

Orthopaedic Device Approval Through the 510(k) Versus Premarket Approval Process: A Financial Feasibility Analysis

, 2019
The two main routes of medical device approval through the Food and Drug Administration are the premarket approval process (PMA), which requires clinical trials, and the 510(k) premarket notification, which exempts devices from clinical trials if they ...
Yang, Brian W.
core  

Value of MRI Outcomes for Preventive and Early‐Stage Trials in Spinocerebellar Ataxias 1 and 3

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Objective To examine the value of MRI outcomes as endpoints for preventive and early‐stage trials of two polyglutamine spinocerebellar ataxias (SCAs). Methods A cohort of 100 participants (23 SCA1, 63 SCA3, median Scale for the Assessment and Rating of Ataxia (SARA) score = 5, 42% preataxic, and 14 gene‐negative controls) was scanned at 3T up ...
Thiago J. R. Rezende, Emilien Petit, Young Woo Park, Sophie Tezenas du Montcel, James M. Joers, Jonathan M. DuBois, H. Moore Arnold, Michal Povazan, Ipek Özdemir, Guita Banan, Romain Valabregue, Philipp Ehses, Jennifer Faber, Chiadi U. Onyike, Peter B. Barker, Jeremy D. Schmahmann, Eva‐Maria Ratai, Sub H. Subramony, Thomas H. Mareci, Khalaf O. Bushara, Henry Paulson, Thomas Klockgether, Alexandra Durr, Tetsuo Ashizawa, Christophe Lenglet, Gülin Öz, READISCA Investigators   +26 more
wiley   +1 more source