FDA Events for iRadimed (IRMD)
This section highlights FDA-related milestones and regulatory updates for drugs developed by iRadimed (IRMD).
Over the past two years, iRadimed has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
MRidium®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
MRidium® 3870 - FDA Regulatory Timeline and Events
MRidium® 3870 is a drug developed by iRadimed for the following indication: MRI infusion pump devices.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MRidium® 3870
- Announced Date:
- May 29, 2025
- Indication:
- MRI infusion pump devices
Announcement
Iradimed Corporation announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its next-generation MRidium® 3870 IV Infusion Pump System.
AI Summary
Iradimed Corporation has announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its next-generation MRidium® 3870 IV Infusion Pump System. The new pump is designed specifically for use in MRI environments and ensures safe fluid delivery during imaging procedures. It features a non-magnetic ultrasonic pump motor along with other non-ferrous components to work reliably within high magnetic fields. An intuitive touchscreen interface and advanced safety features make the device user-friendly and perfect for critical care settings, where it can operate as a single unit or be synchronized with additional pumps to create a multi-channel system.
This clearance confirms that the MRidium® 3870 meets strict safety and performance standards. The FDA approval marks a significant step forward for Iradimed as it continues to lead in MRI-compatible medical devices, promising improved patient safety and enhanced workflow efficiency in healthcare facilities.
Read Announcement
iRadimed FDA Events - Frequently Asked Questions
As of now, iRadimed (IRMD) has not received any FDA approvals for its therapy in the last two years.
In the past two years, iRadimed (IRMD) has reported FDA regulatory activity for MRidium® 3870.
The most recent FDA-related event for iRadimed occurred on May 29, 2025, involving MRidium® 3870. The update was categorized as "FDA Clearance," with the company reporting: "Iradimed Corporation announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its next-generation MRidium® 3870 IV Infusion Pump System."
Currently, iRadimed has one therapy (MRidium® 3870) targeting the following condition: MRI infusion pump devices.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:IRMD) was last updated on 7/12/2025 by MarketBeat.com Staff
