LOS ANGELES--(BUSINESS WIRE)--Glancy Binkow & Goldberg LLP announces that it is investigating potential claims on behalf of investors of IRadimed Corporation (“IRadimed” or the “Company”) (NASDAQ:IRMD) concerning possible violations of federal securities laws. The investigation focuses on the Company’s operations and financial performance.
Please contact Lesley Portnoy at (888) 773-9224 or (310) 201-9150, or at firstname.lastname@example.org to discuss this matter. If you inquire by email please include your mailing address, telephone number and number of shares purchased.
IRadimed develops, manufactures, markets and distributes magnetic resonance imaging (MRI) compatible products, including non-magnetic intravenous infusion pump systems under the mRidium name, in the United States and internationally. The investigation is related to the Company’s September 3, 2014, announcement that IRadimed received a warning letter from the U.S. Food and Drug Administration relating to an April 2014 inspection of the Company's facility. The warning letter states that, among other things:
- A new submission is required under Section 510(k) of the Food, Drug and Cosmetic Act for the Company's IV infusion pump systems due to periodic updates of the software on the Company's previously cleared infusion pumps -- the mRidium 3860 and mRidium 3850.
- 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
- The mRidium 3860+ infusion pump requires separate FDA clearance from the mRidium 3860 and mRidium 3850.
According to the Company, the warning letter further requests that the Company “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.”
Following this news, the price of IRadimed shares dropped more than 31%, or $3.25 per share, to a closing price of $7.15 per share on September 3, 2014, on extremely heavy volume.
If you purchased IRadimed shares, if you have information or would like to learn more about these claims and have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Lesley Portnoy, Esquire, of Glancy Binkow & Goldberg LLP, 1925 Century Park East, Suite 2100, Los Angeles, California 90067, by toll-free telephone at (888) 773-9224 or by telephone at (310) 201-9150, by e-mail to email@example.com, or visit our website at http://www.glancylaw.com. If you inquire by email, please include your mailing address, telephone number and number of shares purchased.
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