
Rachel Neubrander
Director of the Division of Circulatory Support, Structural and Vascular Devices at the FDA; biomedical engineer with PhD from University of Virginia
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Jul 1, 2026
New York Valves 2026: Implications of the Proposed National Coverage Determination for TAVI
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19:51Michael MackMODERATOR
What are your thoughts around the evolution of this and where we stand right now from the FDA perspective?

Rachel NeubranderGUEST
So as someone who joined the FDA just after the original TAVR approvals, it's been really interesting to see this evolution over time.

Rachel NeubranderGUEST
And I think one thing that I've taken away from the whole TAVR space is really that the FDA decisions and the CMS decisions have been complimentary and we've been able to kind of help each other.

Rachel NeubranderGUEST
And I think that just speaks to, you know, we have different charges as agencies, but we really can work in harmony.

Rachel NeubranderGUEST
I think the other thing that's been helpful out of the NCD is just how it has enhanced our ability to truly do total product lifecycle device regulation and continue to gain information about devices, evidence about devices.
54 MINS LATER
