IRadimed Corporation (NASDAQ:IRMD) Q3 2023 Earnings Call Transcript

Roger Susi : Oh, yes, we won’t turn our guns to obtain the CE Mark for that one, probably until mid-late summer that’s one will have the capacity with our team is working on the 510-K to deal with making the tech file and getting our notified body on board to do that. And with the changes in Europe, though they’ve delayed all this MDR stuff for products like ours yet, the notified bodies are still kind of applying the logic of the future mandatory MDR stuff currently. So they’re taking a long time to review tech files and clear them. So an estimate of that would be mid-2025 before we’d have a CE-marked pump. Now having said that, that’s probably accounts for 1/3 of our international business. The other 2/3 of it doesn’t need a CE Mark. And so we’ll enter those markets very soon — much sooner. Those will enter as soon as we’re launched in the U.S.

Operator: [Operator Instructions] This will end the Q&A session. I would now like to turn the conference back to Roger Susi for closing remarks.

Roger Susi : Thank you, operator. Again, it’s with great pleasure to report our Q3 2023 results, demonstrating yet another quarter of strong growth. It is also a great pride that we can guide that we expect strong performance as the year concludes. With that, I look forward to reporting our year-end success. And thank you all for participating in today’s call.

Operator: Thank you. This does conclude the call. You may now disconnect. Have a pleasant day, and enjoy your weekend.