Robbins Arroyo LLP Is Investigating the Officers and Directors of IRADIMED Corporation (IRMD) on Behalf of Shareholders
Robbins Arroyo LLP is investigating whether certain officers and directors of IRADIMED Corporation (NasdaqCM: IRMD) breached their fiduciary duties to shareholders. IRADIMED develops, manufactures, markets, and distributes magnetic resonance imaging (MRI) compatible products in the United States and internationally.
IRADIMED Receives Warning Letter from the U.S. Food and Drug Administration
On September 3, 2014, shares of IRADIMED dropped over 31% to close at $7.15 per share after the company announced that it received a warning letter from the U.S. Food and Drug Administration in relation to an inspection that took place in April 2014. Among other things, the warning letter requires a new submission for the company’s IV infusion pump systems, mRidium 3860 and mRidium 3850, because of the periodic software updates. The IV pumps were previously cleared, but according the warning letter such updates are “significant” changes that could affect safety and effectiveness of the product. In addition to the submissions, the warning letter requires that the mRidium 3860+ infusion pump receive separate FDA approval.
IRADIMED Shareholders Have Legal Options
Concerned shareholders who would like more information about their rights and potential remedies can contact attorney Darnell R. Donahue at (800) 350-6003,or you can complete the form below and we will contact you directly.