Matt Henriksen
๐ค SpeakerAppearances Over Time
Podcast Appearances
Yeah.
I don't know if I can make it out for that one, but I'll be looking forward to that.
Record speed and getting the clinical trial through.
How did the de novo approval process then?
I mean, it sounds like that Amy did a great job of making it as streamlined as possible.
But anytime you have a de novo approval, a new product, what were some of the questions that the FDA was asking you about this such a new technology out there in the markets?
I'm just thinking like a regular 510 approval can sometimes last over six months.
I hear you.
Maybe I'll start with the technical side here.
I noticed in the approval itself, it was called, let me just make sure I got my notes down, glucose range monitoring system.
That's different from the integrated continuous glucose monitoring system that the Dexcoms and the Abbott's have.
Is that something I'm diving in too deep into the difference in the classification name?
Or is that just the start of the technology and to whom the technology is approved for?
They don't need to calculate that into their... Correct.
Interesting.
And so that's also about now being in the type two non-insulin space.
It is a much larger opportunity than that insulin intensive space.
And so, you know, with that market opportunity there, it makes me think about, well, Dexcoms and Abbott's, you know, type two non-insulin intensive products, Stello and Lingo, right?
And it gets me to just basically how you order those products, because you don't need a prescription for those two.
You just go to their website and order it online.