Shorter regulatory review times for high-risk cardiovascular devices correlate with the likelihood of reports of adverse events.
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Acknowledgements
D.B.K. is supported by a Paul Beeson Career Development Award (NIH-NIA AG045963); A.S.K. is supported by a grant from the Laura and John Arnold Foundation and the Harvard Program in Therapeutic Science.
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Regulatory review times and adverse-event reports for cardiovascular devices. (PDF 473 kb)
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Stern, A., Kramer, D., Ouellet, M. et al. Review times and adverse events for cardiovascular devices. Nat Biomed Eng 1, 0013 (2017). https://doi.org/10.1038/s41551-016-0013
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DOI: https://doi.org/10.1038/s41551-016-0013
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