Iradimed (Nasadq:IRMD) announced that it voluntarily withdrew an FDA 510(k) application for its new model MR IV pump.
Winter Springs, Florida-based Iradimed said it learned that the FDA likely wouldn’t have time to finish clearance activities for the pending submission. Upon learning this, the company decided to voluntarily withdraw its application on Oct. 5.
The company committed to collaborating with the FDA to better understand the agency’s concerns. Iradimed said the FDA indicated its intent to provide an increased direct dialogue. This would ensure a “timelier clearance” with a replacement filing, according to a news release.
“We have been engaged in several productive and positive discussions with the FDA,” said Roger Susi, Iradimed president and CEO. “The FDA requested additional information that was not feasible to provide within the 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 further 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.
“I also wish to point out that this withdrawn 510(k) is for a future product and in no way affects our current revenue-generating product portfolio.”
About the Iradimed MRI-compatible infusion pump system
Iradimed develops a non-magnetic intravenous (IV) infusion pump system. It designed it for safety during magnetic resonance imaging (MRI) procedures. Its MRidium MRI-compatible IV infusion pump system features a non-magnetic ultrasonic motor. It also consists of non-ferrous parts, and other unique features. It aims to deliver anesthesia safely and predictably and other IV fluids during various MRI procedures.
The company says its offering provides “a seamless approach” for safe, accurate and dependable fluid delivery. It helps critically ill patients who can’t be removed from medications before, during and after MRI scan. It also aids children and infants who must generally be sedated to remain immobile during a scan.
Preliminary third-quarter results
Iradimed also announced certain preliminary financial results for its third quarter, ended Sept. 30. It expects revenue of approximately $13.4 million. That marks a 23% rise from the same period in the previous year. It also comes in above its guidance of $13.1 million to $13.3 million.
“The third quarter preliminary results represent our highest revenue quarter and the fourth consecutive quarter of record revenues. Again, orders booked in the quarter exceeded our shipments as we continue to add to our backlog for the remainder of 2022 and into early 2023. Domestic unit orders booked in the quarter for our current MRidium 3860 Infusion Pump System were the highest over the last three years and demonstrated the continued strong demand for this product,” said Susi. “As we enter the remainder of 2022 and look forward to 2023, we believe we are positioned to continue to achieve our growth objectives with our current products.”