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Review times and adverse events for cardiovascular devices

Shorter regulatory review times for high-risk cardiovascular devices correlate with the likelihood of reports of adverse events.

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Figure 1: Schematic of an implanted Sapien transcatheter aortic valve.

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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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Correspondence to Ariel Dora Stern or Aaron S. Kesselheim.

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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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