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IRadimed Announces 510K Clearance of the New Non-Magnetic MRidium(TM) MRI IV Pump with Integrated Masimo SET(R) SpO2 Monitoring
Date:8/21/2009

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In hospitals all around the globe, the patient population going to the MRI is growing every day. Today, more and more hospitals are eliminating the long IV lines under their MR Scanner Room doors. Recent studies indicate the addition of 15 to 30 feet of IV Extension Sets significantly reduces the alarm times of syringe and IV pumps, making delivery of critical medications risky at best. Patients are coming to MRI with more IV lines and new types of cases, such as stressing the heart, inter-operative procedures, brain lab suites, cancer patients, and sedations, with many of these patients needing accurate delivery at lower rates and volumes. The MRidium(TM) System has been designed to meet these changing needs by reducing the risk; there is no need for long IV lines or Syringe pumps placed outside the Magnet Room. No need to remember to remove the standard hospital SpO2 Monitor, because the MRidium(TM) Pump has the ability to maneuver right next to the bore of the MRI and deliver medications safely and efficiently. All while being monitored through its wireless remote control, which operates inside the MRI control room.

The MRidium(TM) Pump has the ability to work at the 10,000 Gauss magnetic field environment of 1.5 and 3.0 Tesla MR Scanners, and the system includes the remote control ability for adjusting critical medication deliveries and alarm monitoring from outside the MR Scanner room. The safe placement of the pump is of the utmost importance, because these safety-critical Gauss line limits are invisible and different for every magnet design and strength, which makes it difficult to know where the safe limits are in relation to the MR Scanner. The 10,000 Gauss Line is virtually inside the bore of the MR Scanner in many cases, which allows the use of the MRidium(TM) Pump in close proximity to the MR scanner.

The MRidium(TM) System's remote ability allows clinicians to monitor the infusion progress and make
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SOURCE IRadimed Corporation
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