FDA Approves Pneuma Systems' New Medical Technology

PORTSMOUTH, N.H. — Pneuma Systems Corporation has announced that its PneumaFlow™ Controller and Administration Sets have been accepted into the U.S. Food and Drug Administration’s Safer Technologies Program (STeP) for Medical Devices. This program aims to expedite the regulatory review process, allowing patients quicker access to innovative medical technologies. The initiative, launched in 2021, focuses on devices that provide significant advantages over existing options, enhancing patient care and safety. Peggy McDaniel, Director of Clinical Support at Pneuma, expressed gratitude for the FDA's recognition, emphasizing the importance of this development for both the infusion pump industry and healthcare professionals. With over 50 recalls of infusion systems in the past decade, Pneuma’s innovative approach seeks to address longstanding safety issues and improve the standard of care for patients and nurses alike. The company’s patented technologies and modern components aim to eliminate legacy problems associated with traditional infusion devices. Pneuma Systems, founded by Jeffrey Carlisle, is committed to enhancing the infusion therapy process by removing barriers that hinder nurses' ability to provide optimal patient care. The company’s focus on addressing the unmet needs of clinicians and patients positions it as a forward-thinking player in the medical device industry. While the PneumaFlow™ Controller and Administration Sets are currently under development and have not yet received FDA clearance, the acceptance into the STeP program marks a significant step forward for Pneuma Systems. More information can be found on their website and LinkedIn page.