WINTER SPRINGS, Fla., Nov. 25, 2014 (GLOBE NEWSWIRE) -- IRADIMED CORPORATION (Nasdaq:IRMD), the only provider of non-magnetic intravenous (IV) infusion pump systems that are safe for use during magnetic resonance imaging (MRI) procedures, announced today that it has filed a submission for premarket notification under Section 510(k) of the Federal Food, Drug and Cosmetic Act with the US Food and Drug Administration (FDA) relating to its MRidium 3860+ MRI IV infusion pumps. This submission follows a September 2, 2014 announcement that the Company received a warning letter from the FDA requesting that it cease commercial distribution of its MRI IV infusion pumps and submit a 510(k). The Company's President and CEO Roger Susi stated "following up our September 2nd announcement of the FDA's Warning Letter, we made a 510(k) submission to the agency yesterday with the tremendous combined efforts of many of the staff here at IRADIMED. We now look forward to having the 510(k) reviewed and cleared as expeditiously as possible. We continue to keep our potential and existing customers in close contact and maintain preparedness to resume domestic shipments as soon as clearance is received."
Forward-Looking Statements
This press release includes forward-looking statements as defined in the Private Securities Litigation Act of 1995, particularly statements regarding expectations about future events affecting the Company and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond the Company's control and could cause the Company's actual results to differ materially and adversely from those expressed in its forward-looking statements as a result of various factors, including but not limited to: risks related to the Company's assumptions regarding its ability to receive premarket clearance or successfully make a 510(k) submission, effectively respond to the warning letter, additional actions by or requests from the FDA and unanticipated costs or delays associated with resolution of these matters; as well as other factors discussed in the "Risk Factors" section of the Company's most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. There can be no guarantee that the Company's efforts will be successful and that it will be able to resume commercial distribution of its IV infusion pumps. Although the Company believes that the expectations reflected in its forward-looking statements are reasonable, it does not know whether its expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. The Company does not undertake any obligation to update, amend or clarify these forward-looking statements or the "Risk Factors" contained in the Company's most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
About IRADIMED CORPORATION
IRADIMED CORPORATION is the leading provider of non-magnetic IV infusion pump systems that are safe for use during MRI procedures. Electromechanical medical devices and pumps contain magnetic and electronic parts which generate radio frequency noise, create interference and are dangerous to operate in the presence of the powerful magnet which drives an MRI. The company's mRidium (3850/3860+) IV pump systems have been designed with non-ferrous parts, ceramic ultrasonic motors, non-magnetic mobile stands and other special features in order to safely and predictably deliver anesthesia and other IV fluids during various MRI procedures. The company's pump solution provides a seamless approach to providing IV fluids 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 must generally be sedated in order to remain immobile during an MRI scan. For more information please visit www.iradimed.com. mRidium is a trademark of IRADIMED CORPORATION.