Open AccessPremarket Approval Through the 510(k) Process: Lessons from the Translation Process of Magnetic Resonance Elastography
Author(s) -
Aponte Ortiz Jaime A.,
Konik Ewa,
Eckert Elizabeth C.,
Pepin Kay M.,
GreenbergWorisek Alexandra
Publication year - 2018
Publication title -
clinical and translational science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.303
H-Index - 44
eISSN - 1752-8062
pISSN - 1752-8054
DOI - 10.1111/cts.12581
Subject(s) - process (computing) , translation (biology) , magnetic resonance elastography , magnetic resonance imaging , medicine , nuclear magnetic resonance , computer science , elastography , radiology , chemistry , physics , ultrasound , biochemistry , messenger rna , gene , operating system
Innovations in medical imaging technologies have revolutionized medicine and generated examples of rapid translation to the clinic. Magnetic resonance elastography (MRE) is a noninvasive technique to quantify tissue stiffness. In this commentary, key events in the translation of MRE from laboratory into clinical practice are highlighted. We focus on key science and technology, application to chronic liver diseases, key clinical studies, the FDA approval process, and its influence on current and future medical practice. This article is protected by copyright. All rights reserved.