Correlation Between Shorter Review Times and Reports of Adverse Events for Cardiovascular Devices

 

A recent analysis, published in Nature Biomedical Engineering has found that longer regulatory review times for high-risk cardiovascular medical devices are correlated with fewer adverse event reports, and a decreased likelihood of such reports citing serious injury or death. This raises questions about the trade-offs between increasing patient access to new devices and ensuring patient safety.

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Published on 16. January 2017 in Interesting Reads