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

Related Content

Henry Ford Cancer Institute First in World to Install Viewray MRIdian Linac
News | Image Guided Radiation Therapy (IGRT) | June 19, 2017
The Henry Ford Cancer Institute is the first in Michigan – and first in the world – to offer patients advanced...
The Magnetom Vida with BioMatrix technology
News | Magnetic Resonance Imaging (MRI) | June 16, 2017
The U.S. Food and Drug Administration (FDA) has cleared the Magnetom Vida 3 Tesla (3T) magnetic resonance imaging (MRI...
Stéphane Bordas, Professor in Computational Mechanics at the Faculty of Science, Technology and Communication of the University of Luxembourg, and his team have developed methods to train surgeons, help them rehearse for such complex operations and guide them during surgery

Stéphane Bordas, Professor in Computational Mechanics at the Faculty of Science, Technology and Communication of the University of Luxembourg, and his team have developed methods to train surgeons, help them rehearse for such complex operations and guide them during surgery. Image © Legato Team / University of Luxembourg.

News | Information Technology | June 16, 2017
Researchers from the University of Luxembourg, in cooperation with the University of Strasbourg, have developed a...
New Metamaterial-Enhanced MRI Technique Tested on Humans
News | Magnetic Resonance Imaging (MRI) | May 31, 2017
Scientists from the Netherlands and Russia designed and tested a new metasurface-based technology for enhancing the...
FDA says gadolinium retention in the brain is not a safety issue
Feature | Magnetic Resonance Imaging (MRI) | May 25, 2017
A U.S. Food and Drug Administration (FDA) review of the safety ramifications of gadolinium-based contrast agents for...
Targeted MRI Could Pinpoint Aggressive Prostate Cancers Before They Spread

The ZD2-Gd probe, represented by the orange ball and green arrow, binds to the EDB-FN in the prostate cancer cells with high metastatic potential. This results in a strong MRI signal (upper right). Prostate cancer cells with low metastatic potential have no EDB-FN and so there is no MRI signal (lower right). Credit: Han, et al., Bioconjug Chem-Apr-2017

News | Prostate Cancer | May 24, 2017
A research team funded by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) has engineered a...
News | Image Guided Radiation Therapy (IGRT) | May 24, 2017
The University Medical Centre (UMC) Utrecht in the Netherlands recently treated the first patient as part of a clinical...
Asterias MRI Data Shows AST-OPC1 Cells Prevent Cavitation in Severe Spinal Cord Injury Patients
News | Orthopedic Imaging | May 23, 2017
Asterias Biotherapeutics Inc. recently announced new positive serial magnetic resonance imaging (MRI) data from its...
MRI Offers New Insights Into Tumor Metabolism
News | Magnetic Resonance Imaging (MRI) | May 17, 2017
May 17, 2017 — Tumors, inflammation and circulatory disorders locally disturb the body's acid-base balance.
Study Indicates Q-Collar May Help Protect Football Players' Brain Function
News | Neuro Imaging | May 15, 2017
A new study of high school football players adds to mounting evidence that the Q-Collar may help reduce brain injury...
Overlay Init