IRADIMED CORPORATION (the “Company”) (NASDAQ: IRMD) today announced that the Company voluntarily withdrew its 510(K) application on October 5, 2022, for its next-generation MR IV pump.
Roger Susi, President and Chief Executive Officer of the Company, commented, “We have been engaged in several productive and positive discussions with the FDA. The FDA requested additional information that was not feasible to provide within FDA’s review deadline; therefore, we decided to withdraw our application to provide us more time to understand and resolve the FDA’s concerns. We are confident that after working with the FDA, we will be able to submit a 510(k) application that leads to a timely clearance for the MRidium 3870 Infusion Pump System. It is important to note that this withdrawn 510(k) is for a future product and in no way affects our current revenue-generating product portfolio.”
The Company also announced selected preliminary financial results for the third quarter ended September 30, 2022. Third-quarter revenue is expected to be approximately $13.4 million, up 23% from the prior year and above the Company’s third-quarter guidance of $13.1 million - $13.3 million.
“These third quarter preliminary results represent our highest revenue quarter. It also continues a four-quarter trend of record revenues. Orders booked in the quarter exceeded our shipments as we continue to add to our extensive backlog. Domestic unit orders booked in the quarter for our current MRidium 3860 Infusion Pump System were the highest over the last three years, demonstrating the continued strong demand for this product,” said Roger Susi. “As we enter the remainder of 2022 and onward into 2023, we are positioned to continue to achieve our growth objectives with our current products,” Mr. Susi added.
https://finance.yahoo.com/news/iradimed-corporation-withdraws-510-k-120000972.html
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