iRadimed Corporation filed SEC Form 8-K: Other Events, Financial Statements and Exhibits
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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
Exhibit No. | Description |
99.1 | |
104 | Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101) |