Full Press Release Details
CORPORATION Completes CE Mark Renewal Process For Its MRI Compatible Patient Vital Signs Monitoring System
Winter Springs, Florida, December 12, 2019 - iRadimed
Corporation (NASDAQ: IRMD), a leader in the development of innovative magnetic resonance imaging ("MRI") medical
devices and the only known provider of a non-magnetic intravenous ("IV") infusion pump system and non-magnetic patient
vital signs monitoring system that are designed for use during MRI procedures, today announced that it resumed shipments of its
MRI compatible patient vital signs monitoring systems into European Commission markets after completing the CE Mark renewal process.
"We are very pleased with obtaining the CE Mark renewal
certificate for our patient monitors. With the renewed certificate, we are immediately resuming shipments to the impacted customers
and thank them for their patience," said Leslie McDonnell, President and Chief Executive Officer of the Company.
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.
Our 3880 MRI compatible patient vital signs monitoring system
has been designed with non-magnetic components and other special features to safely and accurately monitor a patient's vital
signs during various MRI procedures. 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. The IRADIMED 3880 has a compact, lightweight design allowing it
to travel with the patient 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. The features
of the IRADIMED 3880 include: wireless ECG with dynamic gradient filtering; wireless SpO2 using Masimo algorithms; non-magnetic
respiratory CO2; non-invasive blood pressure; invasive blood pressure; patient temperature, and; optional advanced multi-gas anesthetic
agent unit featuring continuous Minimum Alveolar Concentration measurements. 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.
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 an EC Certificate or CE Mark for our existing products, 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, warnings or requests from the FDA; our significant reliance on a single product; 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.
Chief Financial Officer
iRadimed Corporation