SAN DIEGO, Sept. 23, 2014 (GLOBE NEWSWIRE) -- The Shareholders Foundation, Inc. announces that a lawsuit was filed on behalf of certain purchasers of shares of Iradimed Corp (IRMD) over alleged Violations of Federal Securities Laws by Iradimed.
If you purchased shares of Iradimed Corp (IRMD), you have certain options and for certain investors are short and strict deadlines running. Deadline: November 10, 2014. Iradimed investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.
The plaintiff alleges that the plaintiff claims that Iradimed Corp allegedly failed to disclose that Iradimed Corp's infusion pump systems had been significantly modified which could significantly affect the safety or effectiveness of the devices, that as such under applicable federal regulations the Company's products are "adulterated" and "misbranded", that Iradimed Corp's mRidium 3860+ infusion pump requires separate FDA clearance from the mRidium 3860 and mRidium 3850, and that Iradimed Corp failed to disclose the material uncertainties and risks that their products were adulterated or misbranded.
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 Company's facility that took place in April 2014. Iradimed Corp said that the warning letter, among other things, stated that a new submission is required 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, that the warning letter stated 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 requested 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.
Those who purchased shares of Iradimed Corp have certain options and should contact the Shareholders Foundation, Inc. by e-mail at mail@shareholdersfoundation.com or call +1 (858) 779-1554.
The Shareholders Foundation, Inc. is a professional portfolio legal monitoring and a settlement claim filing service, which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. The Shareholders Foundation, Inc. is not a law firm. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.