IRadimed Corporation Receives FDA 510(k) Clearance for Next-Generation MRidium® 3870 Infusion Pump System

Reuters
05-29
IRadimed Corporation Receives FDA 510(k) Clearance for Next-Generation MRidium® 3870 Infusion Pump System

WINTER SPRINGS, Fla., May 29, 2025 - Iradimed Corporation $(IRMD)$, a leading provider of innovative medical devices for MRI environments, has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its MRidium® 3870 IV Infusion Pump System. This next-generation, MRI-compatible infusion pump reinforces Iradimed's unique position as the sole supplier of non-magnetic MRI infusion pump devices, a leadership role they have held since the introduction of their first-generation device in 2005. The MRidium® 3870 is designed to enhance patient safety and operational efficiency during MRI procedures, featuring a non-magnetic ultrasonic pump motor and advanced safety features. The company plans a strategic rollout starting in the fourth quarter of 2025, with full commercial distribution expected to increase throughout 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. IRadimed Corporation published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9460018-en) on May 29, 2025, and is solely responsible for the information contained therein.

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