FDA Grants Breakthrough Status to ICU Medical’s Plum Solo™ and Plum Duo™ Precision IV Pumps

ICU Medical Inc has received 510(k) clearance from the U.S. Food and Drug Administration for its new Plum Solo™ precision IV pump. This single-channel pump complements the previously cleared dual-channel Plum Duo™ and marks the completion of the initial rollout of the company’s IV Performance Platform. Updated versions of the Plum Duo pump and LifeShield™ infusion safety software have also received FDA clearance.

The new precision IV pumps are designed to overcome limitations found in traditional systems. While standard pumps may be affected by external conditions and specific setup requirements, the Plum Solo and Plum Duo deliver consistent and accurate infusions under real-world conditions. Both devices use ICU Medical’s proven cassette technology, first introduced in the award-winning Plum 360™, and maintain a delivery accuracy of ±3%.

Key features of the ICU Medical IV Performance Platform include:

High-Precision Delivery: The technology allows for accurate administration of medication, including whole blood and blood products, with minimal impact from external factors like elevation or room temperature.

User-Friendly Interface: The pumps feature colour touchscreen displays—7 inches for the Plum Solo and 10 inches for the Plum Duo—designed for intuitive programming and improved workflow.

Simplified Software Management: Drug libraries and firmware can be updated centrally and remotely, ensuring all devices stay current and consistent across the hospital network.

Full Integration with Electronic Health Records (EHRs): The LifeShield software enables better decision-making by supporting comprehensive IV-EHR connectivity.

Scalable and Future-Focused: LifeShield serves as a unified digital platform that supports ICU Medical’s broader roadmap, which includes next-generation syringe and ambulatory pumps.

The company aims to integrate upcoming devices, such as the next-generation Medfusion™ syringe pump and the CADD™ pain and ambulatory pump, into the LifeShield ecosystem, strengthening its position in delivering advanced, precise, and interoperable infusion solutions.