Iradimed gets FDA clearance for MRI infusion pump system

MRI accessories developer IRadimed has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its MRidium 3870 IV Infusion Pump System.

The device includes a nonmagnetic ultrasonic pump motor, noninterfering radiofrequency emissions, and nonferrous components, as well as a graphical touchscreen user interface. 

MRidium 3870 can operate independently or be combined with additional 3,870 pumps to operate as a four-channel IV infusion pump system for critical care patients. It also features modern drug library software that accommodates multiple patient care area drug listing.

IRadimed said it is planning to roll out the system to select healthcare facilities in the fourth quarter of 2025 and ramp up shipments of the device throughout 2026.