September 5, 2014 (Shareholders Foundation) - An investigation on behalf of investors of Iradimed Corp (NASDAQ:IRMD) shares over potential securities laws violations by Iradimed and certain of its directors and officers in connection certain financial statements was announced.

The investigation by a law firm focuses on possible claims on behalf of purchasers of the securities of Iradimed Corp (NASDAQ:IRMD) concerning whether a series of statements by Iradimed regarding its business, its prospects and its operations were materially false and misleading at the time they were made.

Iradimed Corp reported that its annual Total Revenue rose from $7.69 million in 2012 to $11.34 million in 2013 and that its Net Income increased from $0.97 million in 2012 to $1.94 million in 2013.

On September 2, 2013, Iradimed Corp announced that it received a warning letter from the U.S. Food and Drug Administration (FDA) relating to an inspection of the Companys facility that took place in April 2014.
Iradimed Corp said that the warning letter, among other things, states that a new submission is required under Section 510(k) of the Food, Drug and Cosmetic Act (the FDCA) for the Companys IV infusion pump systems due to periodic updates of the software on the Companys previously cleared infusion pumps, the mRidium 3860 and mRidium 3850, that the warning letter states that such updates are significant modifications that could significantly affect the safety or effectiveness of the devices and therefore the products being sold by the Company are adulterated and misbranded under the FDCA, and that the warning letter indicates that the mRidium 3860+ infusion pump requires separate FDA clearance from the mRidium 3860 and mRidium 3850.
Iradimed Corp also said that the warning letter requests that Iradimed Corp immediately cease activities that result in the misbranding or adulteration of the 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. Shares of Iradimed Corp declined from $10.40 per share on September 2, 2014 to as low as $6.26 per share on September 3, 2014.