NEW YORK, Sept. 12, 2014 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a class action lawsuit has been filed in the United States District Court for the Southern District of Florida on behalf of all persons who purchased or otherwise acquired the securities of IRadimed Corporation ("IRadimed" or the "Company") (Nasdaq:IRMD) during the period between July 15, 2014 and September 2, 2014, inclusive (the "Class Period"). This class action seeks to recover damages against Defendants for alleged violations of the federal securities laws under the Securities Exchange Act of 1934 (the "Exchange Act").
The Complaint alleges that IRadimed failed to disclose that: (i) the Company's infusion pump systems had been significantly modified which could significantly affect the safety or effectiveness of the devices; (ii) as such under applicable federal regulations the Company's products are "adulterated" and "misbranded"; (iii) the Company's mRidium 3860+ infusion pump requires separate FDA clearance from the mRidium 3860 and mRidium 3850; and (iv) the Company failed to disclose the material uncertainties and risks that their products were adulterated or misbranded.
On September 3, 2014, the Company announced that it received a warning letter from the FDA. The warning letter requests that the Company immediately stop all activities that misbrand or adulterate its mRidium 3860 MRI infusion pump, mRidium 3850 MRI infusion pump, and the mRidium 3860+ MRI infusion pump, such as the commercial distribution of the device. This adverse news caused the Company's stock to fall $3.30 per share, or more than 30%, to close at $7.10 per share on September 3, 2014.
If you wish to serve as lead plaintiff, you must move the Court no later than November 10, 2014. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to join the litigation, or to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at tjmckenna@gme-law.com or gegleston@gme-law.com.
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