Pneuma Systems announced that the FDA has added its PneumaFlow infusion controller and administration sets to its Safer Technologies Program (STeP).
STeP, a collaborative program, helps reduce the time required to develop and obtain market approval for eligible devices. The FDA launched STeP in 2021 and modeled the program after its Breakthrough Device Designation program.
The program includes devices that could improve the safety of treatments or diagnoses. These devices treat underlying diseases or conditions that are considered less serious than those treated or diagnosed with devices that may be classified as breakthrough.
“This is a huge milestone,” said Pneuma founder and CEO Jeffrey Carlisle. “Not just for Pneuma, but for the infusion pump industry and, most importantly, for patients and caregivers everywhere.”
According to a press release, the STeP program included only 35 devices at the end of 2023. Pneuma can now work with the FDA through interactive communication, real-time feedback and regulatory support, all leading to a potential 510(k) filing for the company’s infusion technology.
The company developed its PneumaFlow controller to reduce electromechanical complexity and improve the reliability of infusion pumps. Pneuma aims to serve an industry “plagued” by recalls and safety issues. Over the past 12 months, recalls have spread to key infusion technologies manufactured by InfuTronix, Fresenius Kabi, Smiths Medical, Baxter and BD, among others.
“I have been involved with infusion devices, nurse colleagues and patients for decades. Our team is ready to demonstrate and quantify significant improvements in patient care, infusion safety and nurse efficiency. We are grateful that the FDA has given us the chance to verify this innovative approach,” added Peggy McDanielPneuma’s Director of Clinical Support Equities.
