EX-99.1 2 irmd-20250529xex99d1.htm EX-99.1 IRADIMED CORPORATION Announces FDA 510(k) Clearance for MRidium® 3870 Infusion Pump System Winter Springs, Florida, May 29, 2025 - Iradimed Corporation (NASDAQ: IRMD), a global leader in innovative medical devices for MRI environments, today 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. The MRidium® 3870 is poised to strengthen Iradimed’s leadership for MRI-compatible infusion, addressing growing demands for safe and reliable fluid delivery in diagnostic imaging. The MRidium® 3870 features a non-magnetic ultrasonic pump motor, non-interfering RF emissions, and non-ferrous components, ensuring seamless performance in high-magnetic-field environments. Building on Iradimed’s legacy of innovation, this next-generation system introduces an enhanced, intuitive graphical touchscreen user interface and advanced safety features. The 3870 …
Open exhibit ↗Current Report · Items 8.01, 9.01 · 8-K
iRadimed Corporation
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Item 8.01 Other Items On May 29, 2025, iRadimed Corporation (the “Company”) issued a press release (the “Press Release”) announcing that the U.S. Food and Drug Administration has granted 510(k) clearance for its next-generation MRidium® 3870 IV Infusion Pump System (the “MRidium® 3870”).…
Company context
IRADIMED CORPORATION is a leader in developing innovative Magnetic Resonance Imaging (“MRI”) compatible medical devices. We design, manufacture, market, and distribute MRI-compatible medical devices, accessories, disposables, and related services. We are the only known provider of a non-magnetic intravenous (“IV”) infusion pump system specifically designed to be safe for use during MRI procedures. We were the first to develop an infusion delivery system that largely eliminates many of the dangers and problems present during MRI procedures. Standard infusion pumps contain magnetic and electronic components that can create radio frequency interference and are dangerous to operate in the presence of the powerful magnet that drives an MRI system. Our patented MRidium® MRI compatible IV infusion pump system has a non-magnetic ultrasonic motor, uniquely designed non-ferrous parts, and other special features to safely and predictably deliver anesthesia and other IV fluids during various MRI procedures. Our pump solution provides a seamless approach that enables accurate, safe, and dependable fluid delivery before, during, and after an MRI scan, which is essential to critically ill patients who cannot be removed from their vital medications and children and infants who must generally be sedated to remain immobile during an MRI scan.