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Rachel Neubrander

Rachel Neubrander

Director of the Division of Circulatory Support, Structural and Vascular Devices at the FDA; biomedical engineer with PhD from University of Virginia

Jul 1, 2026

Michael MackMODERATOR
19:51
What are your thoughts around the evolution of this and where we stand right now from the FDA perspective?
20:04
So as someone who joined the FDA just after the original TAVR approvals, it's been really interesting to see this evolution over time.
20:15
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.
20:30
And I think that just speaks to, you know, we have different charges as agencies, but we really can work in harmony.
20:38
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.
20:59
And it's been really helpful from that perspective as well.
21:02
Andy, I'm sure you have more comments.

54 MINS LATER

75:07
Rachel?

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