IRADIMED CORPORATION Withdraws 510(k) with Plans to Resubmit After Further Discussions with FDA
iRadimed Corporation (IRMD)
Last iradimed corporation earnings: 4/30 07:00 am
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Source: GlobeNewswire
WINTER SPRINGS, Fla., Oct. 10, 2022 (GLOBE NEWSWIRE) -- IRADIMED CORPORATION (the “Company”) (NASDAQ: IRMD) today announced that the Company voluntarily withdrew its 510(K) application on October 5, 2022, for its next-generation MR IV pump. Roger Susi, President and Chief Executive Officer of the Company, commented, “We have been engaged in several productive and positive discussions with the FDA. The FDA requested additional information that was not feasible to provide within FDA’s review deadline; therefore, we decided to withdraw our application to provide us more time to understand and resolve the FDA’s concerns. We are confident that after working with the FDA, we will be able to submit a 510(k) application that leads to a timely clearance for the MRidium 3870 Infusion Pump System. It is important to note that this withdrawn 510(k) is for a future product and in no way affects our current revenue-generating product portfolio.” The Company also announced selected p
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- IRadimed Corporation (NASDAQ:IRMD) Q1 2024 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
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- IRADIMED CORPORATION Announces First Quarter of 2024 Financial Results and the Declaration of its Regular Quarterly Cash Dividend of $0.15 Per ShareGlobeNewswire
- IRADIMED CORPORATION to Hold 2024 First Quarter Financial Results Conference Call on May 2ndGlobeNewswire
- Iradimed Corporation (NASDAQ: IRMD) had its "buy" rating re-affirmed by analysts at Roth Capital.MarketBeat
IRMD
Earnings
- 5/2/24 - Beat
IRMD
Sec Filings
- 5/9/24 - Form ARS
- 5/9/24 - Form EFFECT
- 5/6/24 - Form S-3/A
- IRMD's page on the SEC website