IRADIMED CORPORATION resumes domestic distribution of infusion pumps

WINTER SPRINGS, Fla., Dec. 22, 2014 (GLOBE NEWSWIRE) -- IRADIMED CORPORATION (Nasdaq:IRMD), the only provider of non-magnetic intravenous (IV) infusion pump systems for use during magnetic resonance imaging (MRI) procedures, announced today that it has resumed domestic distribution of its MRI compatible MRidium 3860 IV infusion pump systems.

This 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). Upon receipt of the warning letter, the Company immediately ceased domestic shipments and began preparing a 510(k) submission. The Company submitted the 510(k) on November 24, 2014 and it was formally accepted for review by the FDA on December 12, 2014. During the FDA's review of the submission, the Company has resumed sales and domestic distribution of its MRidium 3860 IV infusion pump systems. The separately sold DERS (Dose Error Reduction System) option (P/N 1145) will not be made available again until the pending 510(k) is cleared by the FDA. The FDA is aware of the Company's resumption of sales and domestic distribution of the 3860 MRI IV infusion pump systems and the Company's continued withholding of the DERS option. The Company stated it will continue to work with the FDA as it conducts its review of the 510(k) submission.

Chris Scott, the Company's CFO, stated, "Given the timing of this step we expect a marginal increase in revenue and earnings for the fourth quarter 2014 compared to our guidance and expect to issue 2015 revenue and earnings guidance on January 12th."