IRadimed MRI IV pump FDA clearance


IRadimed announces 510K Clearance of the New Non Magnetic MRidium MRI IV Pump with Integrated Masimo SET SpO2 Monitoring

Intravenous products: The United States Food and Drug Administration has granted IRadimed Corporation clearance of its new MRidium 3860+ MRI Infusion System with integrated Masimo SET SpO2 Monitoring. Transport to the MRI for Sedation, Critical Care, and Cardiac Patients to date has required multiple pieces of equipment, with hospital infusion pumps and SpO2 being typically not designed to be integrated and functional in the MRI. Clinicians no longer have to remember each time when they get to the door of the MRI to remove their standard hospital SpO2 equipment so that it does not become a dangerous projectile, or risk a patient burn, in the MR environment. IRadimed has innovatively combined two critically needed technologies for the MRI to increase productivity, patient safety, and ease of transport to, from, and within, the MRI.

The Innovative MRidium 3860+ MRI Infusion System is the first Non Magnetic IV Pump designed specifically for use in the MRI Environment with Integrated Masimo SET technology. “We chose the Masimo SET technology because it has such an excellent reputation in the marketplace. “Masimo’s systems are viewed by most as one of the best monitoring technologies in the world.” said Todd Weber, VP Sales and Marketing. Safety in the MR is the primary concern when it comes to meeting needs for required patient care. These risks are all well known, as essential IV and monitoring equipment can: fly into the bore, cause artifacts on the images, become un-reliable during crucial deliveries of medications and monitoring, or shut down completely when needed the most. Use of improper pulse oximeters has caused severe burns to patients due to the high RF fields involved within MR scanners. “It is critical to have products which have been designed with the utmost care and thorough insight of this harsh and potentially dangerous environment,” said Roger Susi, founder of IRadimed Corporation.

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