secwatch.observer — SEC 8-K summary
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Issuer:     IRADIMED CORP (IRMD)
CIK:        0001325618
Form:       8-K
Filed at:   2022-10-11T23:59:59+00:00
Accession:  0000898432-22-000616
Event type: regulatory
Sentiment:  neutral
Materiality: 0.70
Item codes: 2.02, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Iradimed withdraws 510(k) for MRidium 3870 pump; Q3 revenue $13.4M beats guidance
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- Voluntarily withdrew 510(k) for MRidium 3870 Infusion Pump on Oct 5; plans to resubmit after FDA talks.
- Preliminary Q3 revenue ~$13.4M, up 23% YoY, above guidance of $13.1–$13.3M.
- Record quarterly revenue; fourth consecutive record quarter; orders exceeded shipments.
- Domestic orders for current MRidium 3860 system were highest in three years.
- CEO states withdrawal does not affect current revenue-generating product portfolio.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1325618/000089843222000616/0000898432-22-000616-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1325618/000089843222000616/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0000898432-22-000616

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer