Iradimed Withdraws FDA Application For Updated MR IV Pump System - iRadimed (NASDAQ:IRMD)

Iradimed Corporation IRMD voluntarily withdrew its 510(K) application for its next-generation MRidium 3870 Infusion Pump System.
Roger Susi, President and Chief Executive Officer of the Company, commented, "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.
The company also expects Q3 revenue of approximately $13.4 million, up 23% Y/Y and above its 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," said Roger Susi.
Price Action: IRMD shares are trading 1.53% lower at $27.59 on the last check Monday.