Pneuma Systems announced that the FDA accepted its PneumaFlow infusion controller and administration sets into its Safer Technologies Program (STeP).
STeP, a collaborative program, helps reduce the time needed to develop and obtain marketing authorization for eligible devices. The FDA launched STeP in 2021, modeling the program on its breakthrough devices designation program.
The program covers devices that could improve the safety of treatments or diagnostics. These devices treat underlying diseases or conditions considered less serious than those treated or diagnosed by devices eligible for breakthrough designation.
“This is a tremendous milestone,” said Pneuma Founder and CEO Jeffrey Carlisle. “Not just for Pneuma, but for the infusion pump industry and, most importantly, for patients and nurses everywhere.”
According to a news release, the STeP program featured just 35 devices at the end of 2023. Pneuma can now collaborate with the FDA through interactive communications, real-time feedback and regulatory support. All of this builds up to a potential 510(k) submission for the company’s infusion technology.
The company designed its PneumaFlow controller to reduce electromechanical complexity and improve reliability in infusion pumps. Pneuma aims to address an industry “plagued” with recalls and safety issues. In the last 12 months, the recalls have extended to major infusion technologies made by the likes of InfuTronix, Fresenius Kabi, Smiths Medical, Baxter and BD, among others.
“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,” added Peggy McDaniel, Pneuma’s director of clinical dupport shares.
