IRADIMED CORPORATION Announces FDA 510(k) Clearance for MRidium® 3870 Infusion Pump System

Core Insights - Iradimed Corporation has received FDA 510(k) clearance for its next-generation MRidium® 3870 IV Infusion Pump System, reinforcing its position as the only supplier of non-magnetic MRI infusion pump devices [1][3] - The MRidium® 3870 is designed to meet the increasing demand for safe fluid delivery in MRI environments, featuring advanced technology such as a non-magnetic ultrasonic pump motor and an intuitive touchscreen interface [2][3] Company Overview - Iradimed Corporation specializes in developing innovative MRI-compatible medical devices, including infusion pumps and patient monitoring systems [4][5] - The company is recognized as the only provider of a non-magnetic intravenous infusion pump system specifically designed for MRI procedures, addressing safety concerns associated with standard infusion pumps [5] Product Features - The MRidium® 3870 includes features such as non-interfering RF emissions, non-ferrous components, and the ability to operate as a four-channel IV infusion pump system, enhancing patient safety and workflow efficiency [2][3] - The system also incorporates a modern drug library solution, accommodating various patient care areas and drug listings, which broadens its application in MRI settings [2] Strategic Plans - The company plans to strategically roll out the MRidium® 3870 infusion pump, with initial deployments to select healthcare facilities in Q4 2025, followed by a ramp-up in material shipments throughout 2026 [3]