iRadimed receives FDA 510(k) clearance for next-gen MRidium 3870 infusion pump

IRADIMED CORP

FDA granted 510(k) clearance on May 29, 2025 for the MRidium 3870 IV Infusion Pump System.
Company remains the world's only supplier of non-magnetic MRI infusion pump devices (first device in 2005).
New pump features enhanced touchscreen UI, advanced safety, drug library, and four-channel capability.
Strategic rollout begins with initial units in Q4 2025; full commercial distribution ramps through 2026.
CEO Roger Susi says clearance is a milestone from FDA collaboration on evolving regulatory requirements.

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