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 the development, assessment, and review of 510(k) documentation.
“This is a tremendous milestone,” says Pneuma Systems Founder and CEO Jeffrey Carlisle. “Not just for Pneuma, but for the infusion pump industry and, most importantly, for patients and nurses everywhere.”
The STeP initiative was launched by the FDA in 2021 with a rigorous application process to expedite the development and review of innovative medical devices that offer a significant advantage over currently available options. As of the end of 2023, just 35 devices had been selected for STeP. FDA will collaborate with Pneuma through interactive and frequent communications, real-time feedback, and regulatory support leading to the Company’s 510(k) submission.
Peggy McDaniel, BSN RN, Pneuma’s Director of Clinical Support shares, “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.”
There have been more than 50 FDA recalls of infusion systems in the last 10 years to protect patient safety. Seeing an industry plagued with these recalls and safety issues, Pneuma’s approach eliminates legacy problems and transforms the standard of care for patients and nurses with its patented technologies, modern components, and cutting-edge software. 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. Safer, more reliable technology that measures both flow rate and fluid volume offers opportunities to measurably improve fluid flow, workflow, information flow, and cash flow.