IRADIMED CORPORATION Provides Regulatory Update
June 09 2016 - 7:00AM
IRADIMED CORPORATION (NASDAQ:IRMD)
CURRENT NEWSIRADIMED CORPORATION has received the FDA’s
written response to our appeal of their determination that our
510(k) application for the MRidium 3860+ MRI compatible IV infusion
pump was not substantially equivalent to its predicate device. The
FDA has now reinstated the subject 510(k) and we have been granted
another 180 days to make certain specified changes to several
messages displayed by the infusion pump. Specifically, changes to
messages the infusion pump displays to clarify whether the Dose
Error Reduction System (DERS) is active or inactive and to better
describe the over and under range indications. Further, the FDA’s
response also stated that no additional human factors usability
testing is required.
ACTION PLANThe Company intends to revise the messages identified
by the FDA, consistent with the agency’s explicit recommendations,
and submit the required additional information within the 180 day
period as prescribed in the FDA’s response.
“We are very pleased with this outcome and now have a clear path
to fully resolving this matter. In the coming weeks, we will begin
taking the necessary steps of revising the specific messages
identified by the agency and revalidate the pump’s software. We
anticipate completing this process well before the end of the 180
day period. We are also very pleased with FDA’s conclusion that no
additional human factors usability testing is required,” said Roger
Susi, President and Chief Executive Officer.
BACKGROUNDIn September 2014 we were required by the FDA to stop
selling our MRI compatible infusion pump systems and submit a new
510(k) application because of the addition of the DERS feature. In
response we halted domestic shipments of our infusion pumps and the
DERS feature. In November 2014 we filed the requested 510(k) and in
December 2014, with the FDA’s consent, we resumed shipping the
infusion pump product without the DERS feature. In January 2015,
again with the FDA’s consent, we resumed shipping the infusion pump
with the DERS feature. In March 2016, we received a letter stating
that our infusion pump was not substantially equivalent to its
predicate device. Their finding was based upon a lack of human
factors data supportive of certain aspects of exiting the DERS
feature. The FDA stated that we may resubmit a new 510(k)
application with data showing our infusion pump is substantially
equivalent to similar devices in the market. In April 2016, we
appealed the FDA’s determination to a higher level within the
agency and on May 2, 2016, met with the agency to discuss the
appeal. While the FDA’s response to our appeal did not withdraw
their consent to our continued marketing of the infusion pump with
the DERS system, we cannot guarantee that the FDA will not change
its position on allowing the continued marketing of our MRI
compatible infusion pump systems with DERS.
About IRADIMED CORPORATION
IRADIMED CORPORATION is 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. Standard infusion pumps
contain magnetic and electronic components which can create radio
frequency (RF) 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 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.
MRidium is a trademark of IRADIMED CORPORATION.
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 clearance of its 510(k) submission,
additional actions by or requests from the FDA (including a request
to cease domestic distribution of products) and unanticipated costs
or delays associated with resolution of these matters; our 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 as we focus on fulfilling
orders from our U.S. backlog; 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
IRADIMED CORPORATION
(407) 677-8022
InvestorRelations@iradimed.com
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