J
John Burd
1
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Jun 17, 2026
Tecnis PureSee IOL Fully Launched in the US
4:44
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5:46

Robert StanislaroGUEST
I enjoyed moderating a panel with such distinguished panelists, and I hope those in the room and those not in the room really take to heart the points that were made during this session.

John BurdGUEST
Hi, John Burd here at SightLine, right before ASCRS, and participated in a panel on what's going on at the FDA, and there's been a lot of changes with key people that we've known and interacted with for a long time.

John BurdGUEST
Uh, the changes at high-level administration, we got a broad view all the way from the writers and influencers on the FDA as a whole down to a physician entrepreneur like myself and how we ended up getting our product FDA-approved.

John BurdGUEST
And I think that some of the key insights that came out are, number one, when you're right, you need to fight.

John BurdGUEST
When the data's on your side and the methodology's on your side, find a way to get that message across.

John BurdGUEST
And also, to make sure that the clinical understanding that we have is often really not present at the FDA.

John BurdGUEST
So how do we put the clinical context of a theoretical risk or a small risk into the broader context of what these devastating diseases can do to our patients? And this all has implication from funding at the beginning to hitting endpoints, and if we do, do we get approved, to the costs and the reimbursement and the, the exceptional costs that there are in the US c- healthcare system.