ICU Medical Introduces Its New Category of Infusion Devices With FDA Clearances of Plum Solo™ and Plum Duo™ Precision IV Pumps

New devices address infusion delivery variability and expand ICU Medical IV Performance Platform

San Clemente, Calif. Monday April 7, 2025 - ICU Medical Inc. (NASDAQ:ICUI), a worldwide leader in the development, manufacture and sale of innovative medical devices, has announced 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for the Plum Solo^™ precision IV pump, a single-channel complement to the dual-channel Plum Duo^™. ICU Medical also received 510(k) clearance for updated versions of the Plum Duo precision IV pump and LifeShield^™ infusion safety software, completing the initial launch of the ICU Medical IV Performance Platform. With these FDA clearances, ICU Medical is introducing its new category of precision IV pumps and expanding the ICU Medical IV Performance Platform.

Unlike traditional pumps that rely on specific setups and conditions for accurate delivery, precision IV pumps are designed to address delivery variability while supporting the increasing need for accurate data in modern patient care. Built on the unique cassette technology in the Best in KLAS award-winning Plum 360^™, the Plum Solo and Plum Duo precision IV pumps deliver ±3% accuracy in real-world conditions and eliminate the infusion inconsistencies found in traditional pumps, providing clinicians with predictable performance and reliable infusion documentation.

"Precision IV pumps represent a critical step forward for infusion therapy," said Chad Jansen, corporate vice president and general manager of ICU Medical Infusion Systems. "With the Plum Solo and Plum Duo, we're introducing more than just a new device category-we're setting a new standard. Healthcare teams can now trust not only the delivery of their medications but also the infusion data that supports their decisions, knowing it reflects what patients actually receive."