An investigation for investors in NASDAQ:IRMD shares concerning potential breaches of fiduciary duties by certain directors of Iradimed was announced.
Investors who are current long term investors in Iradimed Corp (NASDAQ:IRMD) shares, have certain options and should contact the Shareholders Foundation at email@example.com or call +1(858) 779 – 1554.
The investigation by a law firm for current long term investors in NASDAQ:IRMD stocks follows a lawsuit filed against Iradimed over alleged securities laws violations. The investigation on behalf of current long term investors in NASDAQ:IRMD stocks, concerns whether certain Iradimed directors are liable in connection with the allegations made in that lawsuit. According to that complaint filed in the U.S.District Court for the Southern District of Florida the plaintiff alleges 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, states that a new submission is required under Section 510(k) of the Food, Drug and Cosmetic Act (the “FDCA”) 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 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.
On April 22, 2016, NASDAQ:IRMD shares closed at $16.20 per share.
Those who purchased NASDAQ:IRMD shares have certain options and should contact the Shareholders Foundation.
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