IRadimed Announces FDA Clearance of MRidium MRI Infusion Pump

The FDA has granted 510(k) clearance for IRadimed's MRidium MRI Infusion Pump, a nonmagnetic smart infusion system designed for the magnetic resonance (MR) environment, enabling patients to receive intravenous medications safely and continuously during the course of a scanning procedure.

The MRidium MRI Infusion Pump has been designed for quick and easy transfer from hospitals' current infusion pumps utilizing a patent-pending design called the MRidium MRI Bypass Infusion Set, which allows customers to Leur-Lock onto their current intravenous (IV) needle-free sets without removing or disconnecting the IV line, reducing the risk of infection from disconnecting tubing with other technologies.

The MRidium pump addresses a critical need for patients on continuous infusion therapy whose diagnosis and treatment increasingly rely on the high-resolution images provided by MR scans. Patients frequently can wait days for an MR scan, until they are stable enough to temporarily suspend their medications. If suspension is not an option, a patient may be removed from the medication risking infection, patient safety or increased discomfort. Many times patients remain connected to the hospital's non-MR compatible infusion pump outside the scanner room by attaching anywhere from 15 to 30 feet of extension tubing. All of these methods affect patient safety and cost, and can interfere with the MR scan causing blurred images.