UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

​

FORM 8-K

​

CURRENT REPORT PURSUANT

TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported): May 29, 2025

IRADIMED CORPORATION

(Exact name of registrant as specified in its charter)

Delaware

(State or other jurisdiction of incorporation)

​

(407) 677-8022

(Registrant’s telephone number, including area code)

​

(Former name or former address, if changed since last report)

​

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

​

Securities registered pursuant to Section 12(b) of the Act:

​

​

​

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

​

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. □

​

​

​

​

​

Item 8.01 Other Items    

​

On May 29, 2025, iRadimed Corporation (the “Company”) issued a press release (the “Press Release”) announcing that the U.S. Food and Drug Administration has granted 510(k) clearance for its next-generation MRidium® 3870 IV Infusion Pump System (the “MRidium® 3870”).

​

The MRidium® 3870 is an advanced,  Magnetic Resonance Imaging (“MRI”) compatible infusion pump that extends the Company’s unique position as the world’s only supplier of non-magnetic MRI infusion pump devices, addressing growing demands for safe and reliable fluid delivery in diagnostic imaging. The MRidium® 3870 features a non-magnetic ultrasonic pump motor, non-interfering radio frequency emissions, and non-ferrous components, ensuring seamless performance in high-magnetic-field environments.

​

A copy of the Press Release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.

​

Item 9.01     Financial Statements and Exhibits.

​

(d)     Exhibits

​

​

​

​

​

​

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

​

​

​

​

​