Premarket Approval Through the 510(k) Process: Lessons from the Translation Process of Magnetic Resonance Elastography

Clin Transl Sci. 2018 Sep;11(5):447-449. doi: 10.1111/cts.12581. Epub 2018 Jul 27.

Authors

Jaime A Aponte Ortiz^{1

2}, Ewa Konik³, Elizabeth C Eckert^{1

3}, Kay M Pepin⁴, Alexandra Greenberg-Worisek^{3

5}

Affiliations

¹ Mayo Clinic Graduate School of Biomedical Sciences, Rochester, Minnesota, USA.
² University of Puerto Rico School of Medicine, San Juan, Puerto Rico, USA.
³ Center for Clinical and Translational Research, Mayo Clinic, Rochester, Minnesota, USA.
⁴ Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.
⁵ Department of Epidemiology, Mayo Clinic, Rochester, Minnesota, USA.

No abstract available

Publication types

Research Support, N.I.H., Extramural

MeSH terms

Device Approval*
Elasticity Imaging Techniques*
Humans
Inventions
Magnetic Resonance Imaging*
Translational Research, Biomedical*
United States
United States Food and Drug Administration

Grants and funding