FDA Adds Pneuma Systems Infusion Tech to its STeP Program

Pneuma Systems Corporation’s PneumaFlow Controller and Administration Sets have been accepted into the U.S. Food and Drug Administration’s (FDA) 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. 
 
“This is a tremendous milestone,” Pneuma Systems Founder and CEO Jeffrey Carlisle said. “Not just for Pneuma, but for the infusion pump industry and, most importantly, for patients and nurses everywhere.”
 
Launched by the FDA in 2021, the STeP initiative’s rigorous application process is designed 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, only 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.
 
“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,” Pneuma Systems Clinical Support Director Peggy McDaniel, B.S.N. R.N., stated. “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. 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, according to Pneuma Systems.
 
Beyond improvements to the underlying flow control technologies, Pneuma Systems 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.
 
Pneuma Systems is a New Hampshire based company founded by Jeffrey Carlisle, who also is the founder of Ivenix, which was recently acquired by Fresenius. The company aims to remove obstacles in the infusion therapy process that interfere with a nurse’s ability to care for the patient. The PneumaFlow Controller and Administration Sets are under development and have not been cleared by the FDA. They are not yet available for commercial sale in the United States.