Iradimed withdraws 510(k) for MRidium 3870 pump; Q3 revenue $13.4M beats guidance

IRADIMED CORP

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.

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