Pneuma Systems’ infusion technology accepted by FDA's Safer Technologies Program (STeP)

image credit- shutterstock

Pneuma Systems Corporation announced the acceptance of its PneumaFlow Controller and Administration Sets into the U.S. Food and Drug Administration's Safer Technologies Program (STeP) for Medical Devices.

STeP is an accelerated regulatory review process to give patients more timely access to innovation by expediting development, assessment, and review of 510(k) documentation. The STeP initiative was launched by the FDA in 2021 to expedite the development and review of innovative medical devices that offer a significant advantage over currently available options. FDA will collaborate with Pneuma on regulatory support leading to the Company's 510(k) submission.

The PneumaFlow Controller provides significant reduction in electromechanical complexity and vastly improved reliability compared to infusion pumps currently on the market. Beyond improvements to the underlying flow control technologies, Pneuma is focused on addressing the unmet needs of clinicians and patients who directly interact with these devices.