FDA approves IV infusion pump system with dose error reduction software

The U.S Food and Drug Administration (FDA) announced that Iradimed Corporation has received clearnance for its MRidium 3860+ MRI-compatible IV infusion pump system, including its Dose Error Reduction System (DERS) software feature.

The Mridium 3860+ MRI allows critically-ill patients who are not able to remove their vital medications or children and infants who are sedated to remain still during an MRI scan to receive an accurate, safe and dependable fluid delivery during or after an MRI scan.

"I am very pleased to have 510(k) clearance of our MRI compatible IV pump and the DERS drug library software option, as it closes a process that has lasted for just over two years. Through this review, we have demonstrated that our IV pump and development processes meet the high standards established by FDA. Additionally, with this clearance behind us, we are now able to allocate our full resources to finalizing the development of our MRI compatible patient vital signs monitoring system and continue planning for its successful launch," said Roger Susi, President and Chief Executive Officer of the Company in a statement.

The extra DERS softaware feature gives users the option to create a unique drug library that establishes the exact values and limits for dose and concentration. The user-programmed infusion has a maximum and minimum for hard limits; for soft limits, high and low limits require user confirmation to exceed.