Medical Device Network

Pneuma Systems wins FDA STeP support for infusion pump control system

Inclusion into the STeP programme means the device will receive expedited approval from the FDA as the company prepares for market.

US-based fluid control company, Pneuma Systems, has become the latest company to be admitted onto the US Food and Drug Administration’s (FDA) Safer Technologies Program (STeP) for Medical Devices with its PneumaFlow Controller system.

Designed as a means of expediting the clearance of certain technologies and device combinations deemed as likely to improve the safety of currently available treatments or diagnostics that target an underlying disease or condition, Pneuma has seen its PneumaFlow Controller and Administration Sets granted an expedited review.

Launched in 2021, the STeP initiative plays host to only 35 devices so far and will see the FDA working closely with the company. Pneuma Systems claims that it is responding to the unmet safety need of clinicians citing more than 50 FDA recalls of infusion systems in the last 10 years, with devices such as the PneumaFlow Controller, designed to optimise and control infusion systems and reduce the complexity of using an infusion pump.

Most notably this week, medical device correction has been issued by Smiths Medical for its CADD-Solis and CADD-Solis VIP infusion pumps due to software issues, with older devices receiving an update to correct issues linked with operational failures for the device.

Peggy McDaniel, Pneuma's director of clinical support, said: "I have been in the trenches with infusion devices, fellow nurses, and patients for decades. Our team is ready to prove and quantify significant improvements in patient care, infusion safety, and nurse efficiency. We are grateful the FDA has given us the chance to verify this innovative approach."

Research by GlobalData estimates that in 2023 the global market for infusion pumps stood at $2.6bn, with that figure estimated to rise to $3bn by 2030. In order to be eligible for the US FDA’s STeP Program a device must be subject to premarket approval applications (PMAs), premarket notification (510(k)) or requests for De Novo classification.

Pneuma founder and CEO, Jeffrey Carlisle, said: “This is a tremendous milestone, not just for Pneuma, but for the infusion pump industry and, most importantly, for patients and nurses everywhere."