iRadimed announces FDA 510k clearance for MRidium 3870 infusion pump system

Iradimed (IRMD) announced that the U.S. Food and Drug Administration, FDA, has granted 510(k) clearance for its next-generation MRidium 3870 IV Infusion Pump System. This advanced, MRI-compatible infusion pump extends Iradimed’s unique position as the world’s only supplier of non-magnetic MRI infusion pump devices, established with our first-generation device in 2005. “We are thrilled to receive FDA 510(k) clearance for the MRidium 3870, a milestone that underscores our commitment to advancing MRI-compatible medical technology,” said Roger Susi, President and CEO of Iradimed Corporation. “This long-awaited clearance reflects our productive collaboration with the FDA to meet evolving and stringent regulatory requirements. The MRidium 3870 empowers clinicians to deliver critical IV fluids and medications safely and predictably in MRI environments, improving patient outcomes and operational efficiency.”