Iradimed Withdraws 510(k) Application for Infusion Pump System

Iradimed has withdrawn its 510(k) application for its MRidium 3870 infusion pump system, a device the company says is a next-generation pump for delivering IV medications during a magnetic resonance imaging (MRI) scan.

An MRI IV pump is needed for some patients, such as those who are critically ill and cannot be removed from vital medications, as well as children and infants who must generally be sedated to remain immobile during an MRI scan.

The company withdrew its application because it said it could not meet the deadline the FDA set for additional information. Iradimed said it plans on resubmitting the 510(k) application after working with the FDA on outstanding product clearance issues.