IRADIMED CORPORATION Announces FDA 510(k) Clearance of MRI Compatible Patient Vital Signs Monitor
October 26 2017 - 7:00AM
IRADIMED CORPORATION (NASDAQ:IRMD), today announced FDA 510(k)
clearance of its 3880 Magnetic Resonance Imaging (“MRI”) compatible
patient vital signs monitoring system.
“We are excited to announce receipt of FDA 510(k) clearance and
launch our revolutionary MRI compatible patient vital signs
monitoring system to U.S. customers. The IRADIMED 3880
monitor’s compact non-magnetic design positions IRADIMED as
the only company in the world with a MRI compatible patient monitor
that can be used to transport patients from the critical care
departments of hospitals to the MRI scanner room and back to
critical care without an interruption in vital signs monitoring. It
has an easy-to-use design and unique wireless tablet remote control
that allows for the effective communication of vital signs
information to clinicians,” said Roger Susi, President and Chief
Executive Officer of the Company.
The IRADIMED 3880 introduces a compact and lightweight design to
the MRI compatible patient vital signs monitoring market,
facilitating the transportation of patients from their critical
care unit, to the MRI and back, resulting in increased patient
safety through uninterrupted vital signs monitoring and decreasing
the amount of time critically ill patients are away from critical
care units. It is the smallest, most portable MRI monitor on the
market.
The IRADIMED 3880 MRI compatible patient vital signs
monitoring system has been designed with non-magnetic components
and other special features in order to safely and accurately
monitor a patient’s vital signs during various MRI procedures.
The IRADIMED 3880 monitor is rated for operations in magnetic
fields up to 30,000 gauss, which means it can operate virtually
anywhere in the MRI scanner room.
“With the 3880 monitor’s record setting 30,000 gauss rating,
non-magnetic design, small form factor and optional tablet that
allows for the remote viewing of patient vital signs and control of
the monitoring unit from the MRI control room, the IRADIMED
3880 brings a unique and fresh solution to the MRI patient
monitoring market,” said Susi.
The features of the IRADIMED 3880 include: wireless ECG
with dynamic gradient filtering; wireless SpO2 using Masimo®
algorithms; respiratory CO2; non-invasive blood pressure; patient
temperature, and; optional advanced multi-gas anesthetic agent unit
featuring continuous Minimum Alveolar Concentration
measurements.
About IRADIMED CORPORATION
IRADIMED CORPORATION is a leader in the development of
innovative MRI compatible medical devices. We are the only known
provider of non-magnetic intravenous (IV) infusion pump systems
that are specifically designed to be safe for use during magnetic
resonance imaging (MRI) procedures. We were the first to develop an
infusion delivery system that largely eliminates many of the
dangers and problems present during MRI procedures. Our patented
MRidium® MRI compatible IV infusion pump system has been designed
with a non-magnetic ultrasonic 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. Our pump solution provides a seamless approach that
enables accurate, safe and dependable fluid delivery before, during
and after an MRI scan, which 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.
For more information please visit www.iradimed.com.
Media Contact:Chris ScottChief Financial OfficerIRADIMED
CORPORATION(407) 677-8022 InvestorRelations@iradimed.com
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