---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-25-008245"
form_type: "8-K"
ticker: "IRMD"
cik: "0001325618"
company_name: "IRADIMED CORP"
filed_at: "2025-05-29T23:59:59+00:00"
generated_at: "2026-05-20T05:30:35.818880+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# iRadimed receives FDA 510(k) clearance for next-gen MRidium 3870 infusion pump

## Summary
- FDA granted 510(k) clearance on May 29, 2025 for the MRidium 3870 IV Infusion Pump System.
- Company remains the world's only supplier of non-magnetic MRI infusion pump devices (first device in 2005).
- New pump features enhanced touchscreen UI, advanced safety, drug library, and four-channel capability.
- Strategic rollout begins with initial units in Q4 2025; full commercial distribution ramps through 2026.
- CEO Roger Susi says clearance is a milestone from FDA collaboration on evolving regulatory requirements.

## SEC filing metadata
- accession: 0001558370-25-008245
- form_type: 8-K
- ticker: IRMD
- cik: 0001325618
- company_name: IRADIMED CORP
- filed_at: 2025-05-29T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1325618/000155837025008245/0001558370-25-008245-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1325618/000155837025008245/irmd-20250529x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-25-008245
- JSON: https://secwatch.observer/filing/0001558370-25-008245.json
- Plain text: https://secwatch.observer/filing/0001558370-25-008245.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.