Early experience with the FDA's Breakthrough Devices program

James L Johnston¹, Sanket S Dhruva^{2

3}, Joseph S Ross^{4

5

6}, Vinay K Rathi⁷

Affiliations

¹ Yale University School of Medicine, New Haven, CT, USA.
² San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA.
³ Department of Medicine, University of California, San Francisco School of Medicine, San Francisco, CA, USA.
⁴ Center for Outcomes Research and Evaluation (CORE), Yale-New Haven Hospital, New Haven, CT, USA.
⁵ Section of Health Policy and Administration, Department of Epidemiology and Public Health, Yale University School of Medicine, New Haven, CT, USA.
⁶ Section of General Internal Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.
⁷ Department of Otolaryngology - Head and Neck Surgery, Massachusetts Eye and Ear Infirmary, Boston, MA, USA. vinay_rathi@meei.harvard.edu.

James L Johnston et al. Nat Biotechnol. 2020 Aug.

. 2020 Aug;38(8):933-938.

doi: 10.1038/s41587-020-0636-7.

James L Johnston¹, Sanket S Dhruva^{2

3}, Joseph S Ross^{4

5

6}, Vinay K Rathi⁷

¹ Yale University School of Medicine, New Haven, CT, USA.
² San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA.
³ Department of Medicine, University of California, San Francisco School of Medicine, San Francisco, CA, USA.
⁴ Center for Outcomes Research and Evaluation (CORE), Yale-New Haven Hospital, New Haven, CT, USA.
⁵ Section of Health Policy and Administration, Department of Epidemiology and Public Health, Yale University School of Medicine, New Haven, CT, USA.
⁶ Section of General Internal Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.
⁷ Department of Otolaryngology - Head and Neck Surgery, Massachusetts Eye and Ear Infirmary, Boston, MA, USA. vinay_rathi@meei.harvard.edu.

No abstract available

References

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1. Rising, J. P. & Moscovitch, B. PLoS One 10, e0117235 (2015). - DOI
1. Makower, J., Meer, A. & Denend, L. FDA impact on U.S. medical technology innovation: a survey of over 200 medical technology companies. https://www.advamed.org/sites/default/files/resource/30_10_11_10_2010_St... (2010).
1. Holmes, D. R. Jr. et al. JACC Cardiovasc. Interv. 9, 626–628 (2016). - DOI