FDA clears Iradimed’s MRI-safe IV infusion pump

The MRidium 3860+ infusion pump system allows patients to undergo MRI procedures without being disconnected from their intravenous medications. Image: Iradimed

Iradimed picked up an FDA nod for its MRI-compatible intravenous infusion pump system, which enables patients who can’t be disconnected from IV medication to undergo MRI scanning. The company will now turn to commercializing the device.

The MRidium 3860+ infusion pump system incorporates a non-magnetic motor and non-ferrous components to ensure the safe and predictable delivery of IV fluids, such as anesthesia, during MRI procedures. With a wide range of infusion rates, the system can be used to sedate pediatric patients for an MRI or deliver sustained medications for critically ill patients, according to a statement.

The device includes Iradimed’s Dose Error Reduction System (DERS) software, which enhances patient safety and makes it easier for caregivers to administer intravenous meds. The software allows users to program a drug library for each patient and to set up hard and soft limits for the dose and concentration of drugs.

“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,” said CEO Roger Susi in the statement. “ … 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.”

In January last year, New Jersey-based Flowonix announced the FDA approved the PMA supplement for its implantable Prometra II infusion pump, allowing the device to be used during an MRI scan.