New Hampshire company poised to disrupt recall-plagued infusion therapy market
PORTSMOUTH, N.H., Aug. 26, 2024 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has initiated more than 50 recalls of infusion systems in the last 10 years to protect patients. Infusion therapy is one of the most widely used treatments in healthcare, and represents one of the industry’s greatest safety challenges. Devices used to deliver intravenous fluids have been plagued with electromechanical, safety, performance, and reliability issues for decades.
Pneuma Systems Corporation eliminates legacy problems to transform the standard of care for patients and nurses by leveraging patented technologies, modern components and cutting-edge software. The FDA has added Pneuma to its selective Safer Technologies Program (STeP) for Medical Devices, which accelerates the regulatory review for medical devices that offer significant advantages over currently available options.
At least 2.3 million pumps are based on recall-prone designs and are especially vulnerable for disruption by Pneuma.
The immediately available market is large: Pneuma has identified 2.3 million devices that are unable to match its performance metrics; each installed device generates more than $1,000 in annual revenue for the device manufacturer.
The Pneuma platform is well positioned to modernize these vital systems and improve both patient safety standards and hospital economics. “Our PneumaFlow™ Controller provides a significant reduction in electromechanical complexity and vastly improved reliability compared to infusion pumps currently on the market,” says Jeffrey Carlisle, Founder and CEO at Pneuma. “The technology is the easy part, with more than 30 inventions in a modern platform that integrates connectivity and security from the start. More importantly, we are fully dedicated to improving patient safety, experience, and outcome.”
About Pneuma
Pneuma Systems is a New Hampshire based company founded by Jeffrey Carlisle, who also is the founder of infusion pump and medical device businesses subsequently acquired by Boston Scientific and Fresenius.
The U.S. FDA recently selected the PneumaFlow™ Controller and Administration Sets for its Safer Technologies Program (STeP) for Medical Devices, which gives patients faster access to innovation by expediting 510(k) review for medical devices which offer clear advantages over current options.
More information about Pneuma Systems is available at www.pneuma-systems.com or at LinkedIn.
Pneuma Systems Corporations 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.
SOURCE Pneuma Systems Corporation