Pneuma Systems recently announced that its PneumaFlow infusion controller and administration sets have been accepted into the U.S. Food and Drug Administration’s (FDA) Safer Technologies Program (STeP). This program aims to expedite the regulatory process for medical devices that significantly enhance patient safety and treatment efficacy. Since its launch in 2021, the STeP initiative has featured only a limited number of devices, with just 35 selected for participation by the end of 2023.
The STeP program facilitates collaboration between companies and the FDA, allowing for interactive communications, real-time feedback, and comprehensive regulatory support. This assistance will be invaluable as Pneuma prepares to submit its 510(k) application, essential for gaining market clearance for medical devices. The PneumaFlow controller aims to address critical safety concerns that have plagued the infusion pump industry, particularly given the more than 50 recalls over the past decade due to safety issues.
Pneuma's CEO, Jeffrey Carlisle, highlighted this acceptance as a significant achievement for the company and the infusion pump sector as a whole. The company’s approach is focused on improving patient care, infusion safety, and nurse efficiency, all crucial components in healthcare delivery. Peggy McDaniel, the director of clinical support at Pneuma, expressed her enthusiasm for the potential impact of the PneumaFlow technology on patient outcomes, reflecting her extensive experience with infusion devices in clinical settings.
By integrating advanced technologies and innovative design elements, Pneuma Systems is poised to deliver a safer, more reliable solution for fluid control in medical settings. The inclusion of PneumaFlow in the STeP program not only underscores the company's commitment to enhancing safety but also signals a transformative shift in standards of care for healthcare professionals and patients alike.
This partnership with the FDA marks a pivotal moment for Pneuma Systems as it aims to bring its groundbreaking infusion technology to market, ultimately improving healthcare experiences for both providers and patients.
