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Peer-Reviewed Publication
Catheter Cardiovasc Interv2022;99(6):1784-1788.May 1, 2022Journal Article

Regulatory strategies for early device development and approval.

David R Holmes1, Rick Geoffrion2, Jon Hunt3, Robert Chip Hance4, Martin B Leon5, Michael J Mack6, Aaron V Kaplan7
1Mayo Clinic, Rochester, Minnesota, USA.
2Cyrano Therapeutics, Delray Beach, Florida, USA.
3HeartBeam Inc, Santa Clara, California, USA.
4Regatta Medical, Bannockburn, Illinois, USA.
5Department of Medicine, Columbia University Medical Center and Center for Interventional Vascular Therapy, Columbia University, New York, New York, USA.
6Department of Cardiovascular Surgery, Baylor Health Care System, and Baylor Scott and White The Heart Hospital-Plano Research Center, Plano, Texas, USA.
7Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
PubMed DOI

Abstract

The development of new technology to treat unmet clinical needs is an important component of modern cardiovascular disease. The need for this has been emphasized in the past several years beginning with the Food and Drug Administration (FDA) guidance document on Early Feasibility Studies in 2012 and then the 21st Century Cures legislation. A number of steps need to be considered in this process by…

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