Quentin Blackford
Management
Hey, Marie. So we now have both 510(k)s on file with the FDA. Keep in mind that we filed the first one right at the turn of the year. The second one got filed just a matter of weeks later. The first one really focused on the letter-to-file matters that we had made a decision on in history that we agreed to bring into a 510(k) process, and then the second one really on the design enhancements, design features that we’ve been working on with the FDA, which is really around patient notification, improving the ability for the patient to see on the patch itself if they’re approaching, say, a max trigger limit or for the physician to see it right in the Zio Suite tool. Those have been submitted. We have not engaged with the FDA in any back-and-forth on those 510(k)s just yet. I would expect we’ll get some questions back here shortly, but based upon all the dialogue that we’ve had to-date, I feel very good about those submissions. The FDA knows exactly what was going to be in those submissions, had worked with us on whether we should put them into one submission or split them into two submissions, and so I feel good about the fact that they’re very much aware of what’s in there and there’s been a great line of communication between the two of us. I would expect somewhere around the mid-part of the year, just after going back-and-forth, answering their questions, call it, roughly a six-month process, that we should see the formal approval of those two 510(k)s, which doesn’t really change anything with respect to how we’re positioning or selling the product in the market, but certainly puts that aspect behind us in terms of closing out the 510(k) itself. The other thing that, I would say that, I just think is clarifying and important, throughout this process of working with the FDA on the Zio AT product, and we knew there were some questions earlier on around MCT. Through working with them, ultimately they’ve created a new category code themselves, which is more or less deemed to be MCT for ambulatory cardiac monitoring and we are the first product that’s been put into that new category code. So, again, through the collaboration of the teams, working with the FDA, answering the questions they had around it, I think, that’s a big first step as we step into this new category code, just being the first product into it that demonstrates just the good progress that’s taken place between the two entities, being the FDA and ourselves. So we’re excited with what we’re seeing there.