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Early experience with the FDA’s Breakthrough Devices program

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Fig. 1: Number of FDA-designated breakthrough devices between 13 December 2016 and 1 January 2020.


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Correspondence to Vinay K. Rathi.

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Competing interests

In the past 36 months, J.S.R. received research support through Yale University from Medtronic, Inc. and the FDA to develop methods for postmarket surveillance of medical devices (U01FD004585), from the CMS to develop and maintain performance measures that are used for public reporting (HHSM-500-2013-13018I), and from the Blue Cross Blue Shield Association to better understand medical technology evaluation. J.S.R. currently receives research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, from the FDA to establish the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NESTcc), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164, R01HL144644), and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International and to establish the Collaboration for Research Integrity and Transparency (CRIT) at Yale. S.S.D. reports receiving travel support from the FDA and the National Evaluation System for Health Technology (NESTcc). J.L.J. has received support from the FDA through the CERSI program. Research reported in this publication was supported by National Heart, Lung and Blood Institute of the National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute or the National Institutes of Health under Award Number T35HL007649.

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Johnston, J.L., Dhruva, S.S., Ross, J.S. et al. Early experience with the FDA’s Breakthrough Devices program. Nat Biotechnol 38, 933–938 (2020).

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