Iradimed Corporation (NASDAQ: IRMD) has announced that its next-generation Mridium® 3870 IV infusion pump system has received FDA 510(k) clearance, positioning the company as the sole supplier of non-magnetic MRI infusion pump devices. The new system features a non-magnetic ultrasonic pump motor, non-interfering RF emissions, and non-ferrous components, ensuring seamless performance in high-magnetic-field environments.
The Mridium® 3870 also introduces an enhanced, intuitive graphical touchscreen user interface and advanced safety features. It can operate independently or be combined with additional pumps to function as a four-channel IV infusion pump system for critical care patients. Furthermore, it features a modern drug library solution that accommodates multiple patient care area drug listings, catering to a wide variety of MRI applications and patient needs.
According to Roger Susi, President and CEO of Iradimed Corporation, the FDA clearance reflects the company's commitment to advancing MRI-compatible medical technology. He emphasized that the Mridium® 3870 empowers clinicians to deliver critical IV fluids and medications safely and predictably in MRI environments, ultimately improving patient outcomes and operational efficiency.
Iradimed plans a strategic rollout of the newly FDA-cleared Mridium® 3870 infusion pump, with initial unit deployment to select healthcare facilities in the fourth quarter of 2025. Material shipments towards full commercial distribution are expected to ramp up throughout 2026.
As a leader in developing innovative MRI-compatible medical devices, Iradimed Corporation has established itself as the only known provider of a non-magnetic IV infusion pump system designed for safe use during MRI procedures. The company's patented Mridium® MRI-compatible IV infusion pump system has been developed to safely and predictably deliver anesthesia and other IV fluids during various MRI procedures, addressing critical patient needs.
Furthermore, Iradimed's 3880 MRI-compatible patient vital signs monitoring system, designed with non-magnetic components and special features, operates dependably in magnetic fields up to 30,000 gauss. This system allows for uninterrupted vital signs monitoring, contributing to increased patient safety and decreased time critically ill patients are away from critical care units.
The company's commitment to innovation and addressing the evolving needs of healthcare providers is evident in the advancements made with the Mridium® 3870 IV infusion pump system and the 3880 MRI-compatible patient vital signs monitoring system. These developments are poised to make a significant impact on patient safety and workflow efficiency during MRI scans. Today the company's shares have moved 13.46% to a price of $58.615. For more information, read the company's full 8-K submission here.
