In Medtech, Real-World Evidence is Moving Beyond Theory to Regulatory Use

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ARTICLE SUMMARY:

This year’s annual meeting of ISPOR highlighted efforts to incorporate RWE as a standard tool in regulatory evaluation of medical devices, aided by the rapid digitization of healthcare data and its tremendous potential to reset how FDA calculates risk in assessing device innovation.

The enormous, messy process of optimizing healthcare data that we are amassing at unfathomable rates is well underway.

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