Technology | Magnetic Resonance Imaging (MRI) | January 17, 2017

Iradimed Corp. Receives FDA Clearance for MRI-compatible IV Infusion Pump

MRIdium 3860+ features Dose Error Reduction System software to create unique drug library, establish nominal values and limits for specified protocols

Iradimed, FDA clearance, MRIdium 3860+ IV infusion pump system, MRI-compatible,

January 17, 2017 — Iradimed Corp. announced in December that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its MRidium 3860+ magnetic resonance imaging (MRI)-compatible IV infusion pump system, including its Dose Error Reduction System (DERS) software feature.

The MRidium 3860+ MRI-compatible IV infusion pump system provides a seamless approach that enables accurate, safe and dependable fluid delivery before, during and after an MRI scan. This is important to critically-ill patients who cannot be removed from their vital medications, and children and infants who must generally be sedated in order to remain immobile during an MRI scan.

The DERS software feature incorporates the latest dosing safety features for patients. The system enables users to create a unique drug library and establish nominal values and limits for dose and concentration for specified infusion protocols. With DERS, patient safety and user convenience are supported by user-programmed infusion hard limits (maximum and minimum) and soft limits (high and low limits that require user confirmation to exceed).

The MRidium 3860+ system has been designed with a non-magnetic motor, uniquely-designed non-ferrous parts and other special features in order to safely and predictably deliver anesthesia and other IV fluids during various MRI procedures. The system can operate dependably in the presence of 0.2T to 3T magnets and is fully operational up to the 10,000 gauss-line. This means it is highly versatile and can operate virtually anywhere in the MRI scanner room, including close to the MRI scanner.

The MRidium 3860+ has a 10-key numeric input keypad, making the system easy to accurately program and operate. The pumping range of 0.1 mL per hour to 1,400 mL per hour provides a broad range of fluid flow control. A broad range of infusion rates supports differing patient needs, including low levels for pediatric sedation, mid-levels for continued IV infusion of medications to critically-ill patients, and high levels in the event of emergency situations.

The pump system includes proprietary single-use IV tubing sets, a non-magnetic pole and a lithium battery. In addition, Iradimed offers optional upgrade systems including the 3865 Remote/Control, 3861 Side Car, Dose Error Reduction System and an SpO2 monitor.

For more information: www.iradimed.com

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