Three years after the US FDA released a guidance to use real-world evidence in premarket applications, the stakeholder group MDIC has unveiled a framework for how IVD RWE can be captured and used by sponsors for premarket applications.

CVRx CEO Nadim Yared has moved up on the board of directors at the Medical Device Innovation Consortium as its new chair. The public-private partnership group that formed in 2012 has been effective in working with the US Food and Drug Administration to develop new regulations.

Two months into the job, Medical Device Innovation Consortium CEO Pamela Goldberg talks about the organization's work running the NEST Coordinating Center, its efforts to engage the Medicare agency, early feasibility studies and its work with US FDA on Case for Quality.