WINTER SPRINGS, Fla., Dec. 19, 2018 (GLOBE NEWSWIRE) -- IRADIMED CORPORATION (NASDAQ:IRMD), a leader in the
development of innovative magnetic resonance imaging (“MRI”) medical devices, today announced FDA 510(k) clearance of its 3883
MRI-compatible invasive blood pressure module for use with its 3880 MRI compatible patient vital signs monitoring system.
“This newly cleared device represents a feature extension to the 3880 MRI-compatible patient monitoring system, which we
launched in the U.S. just over a year ago. With the invasive blood pressure module, we now offer advanced monitoring capabilities
to our customers,” said Roger Susi, President and Chief Executive Officer of the Company.
The 3883 MRI-compatible invasive blood pressure module is available as an option to the 3880 MRI-compatible patient vital signs
monitor.
“Customers can now provide a more comprehensive suite of vital signs monitoring while transporting patients from hospital
critical care departments to the MRI scanner room and back to critical care while maintaining continuous vital signs monitoring,”
said Susi.
About the 3880 MRI Compatible Patient Vital Signs Monitoring System
IRADIMED designed the 3880 MRI-compatible patient vital signs monitoring system using non-magnetic components and other
special features enabling the safe and accurate monitoring of a patient’s vital signs during various MRI procedures. The
IRADIMED 3880 MRI-compatible patient vital signs monitoring system has an easy-to-use design and allows for the effective
communication of patient vital signs information to clinicians.
Additionally, the IRADIMED 3880 MRI-compatible vital signs monitoring system’s compact and lightweight design enables
uninterrupted monitoring during transport, resulting in increased patient safety and decreasing the amount of time critically ill
patients are away from critical care units.
Available features of the IRADIMED 3880 system include:
- Wireless ECG with dynamic gradient filtering;
- Wireless SpO2 using Masimo® SET algorithms;
- Non-magnetic respiratory CO2;
- Non-invasive blood pressure;
- Invasive blood pressure;
- Patient temperature;
- Advanced Masimo® multi-gas anesthetic agent unit featuring continuous Minimum Alveolar Concentration measurements.
The IRADIMED 3880 system operates dependably in magnetic fields up to 30,000 gauss, which means it can operate virtually
anywhere in the MRI scanner room.
About IRADIMED CORPORATION
IRADIMED CORPORATION is a leader in the development of innovative magnetic resonance imaging (“MRI”) compatible medical
devices. We are the only known provider of a non-magnetic intravenous (“IV”) infusion pump system that is specifically designed to
be safe for use during 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. Standard infusion pumps contain magnetic and electronic components which can
create radio frequency interference and are dangerous to operate in the presence of the powerful magnet that drives an MRI system.
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 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 to remain immobile during an MRI scan.
For more information please visit www.iradimed.com.
Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Act of 1995, particularly
statements regarding our expectations, beliefs, plans, intentions, future operations, financial condition and prospects, and
business strategies. These statements relate to future events or our future financial performance or condition and involve unknown
risks, uncertainties and other factors that could cause our actual results, level of activity, performance or achievement to differ
materially from those expressed or implied by these forward-looking statements. The risks and uncertainties referred to above
include, but are not limited to, risks associated with the Company’s ability to receive FDA 510(k) clearance for new products;
unexpected costs, delays or diversion of management’s attention associated with the design, manufacture or sale of new products;
the Company’s ability to implement successful sales techniques for existing and future products and evaluate the effectiveness of
its sales techniques; additional actions by or requests from the FDA; our significant reliance on a single product; unexpected
costs, expenses and diversion of management attention resulting from the FDA warning letter; potential disruptions in our limited
supply chain for our products; a reduction in international distribution; actions of the FDA or other regulatory bodies that could
delay, limit or suspend product development, manufacturing or sales; the effect of recalls, patient adverse events or deaths on our
business; difficulties or delays in the development, production, manufacturing and marketing of new or existing products and
services; changes in laws and regulations or in the interpretation or application of laws or regulations. Further information on
these and other factors that could affect the Company’s financial results is included in filings we make with the Securities and
Exchange Commission from time to time. All forward-looking statements are based on information available to us on the date hereof,
and we assume no obligation to update forward-looking statements.
Media Contact:
Chris Scott
Chief Financial Officer
(407) 677-8022
InvestorRelations@iradimed.com
