Expedited FDA review brings safer technologies to patients
sooner
PORTSMOUTH, N.H., Aug. 12,
2024 /PRNewswire/ -- Pneuma Systems Corporation is
pleased to announce the acceptance of its PneumaFlow™ Controller
and Administration Sets into the U.S. Food and Drug
Administration's Safer Technologies Program (STeP) for Medical
Devices. STeP is an accelerated regulatory review process to give
patients more timely access to innovation by expediting
development, assessment, and review of 510(k)
documentation.
Pneuma defines a new standard of care
in infusion therapy
"This is a tremendous milestone," says Pneuma Founder and CEO
Jeffrey Carlisle. "Not just for
Pneuma, but for the infusion pump industry and, most importantly,
for patients and nurses everywhere."
The STeP initiative was launched by the FDA in 2021 with a
rigorous application process to expedite the development and review
of innovative medical devices that offer a significant advantage
over currently available options. As of the end of 2023, just
35 devices had been selected for STeP. FDA will collaborate
with Pneuma through interactive and frequent communications,
real-time feedback, and regulatory support leading to the Company's
510(k) submission.
Peggy McDaniel, BSN RN, Pneuma's
Director of Clinical Support shares, "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."
There have been more than 50 FDA recalls of infusion systems in
the last 10 years to protect patient safety. Seeing an
industry plagued with these recalls and safety issues, Pneuma's
approach eliminates legacy problems and transforms the standard of
care for patients and nurses with its patented technologies, modern
components, and cutting-edge software. The PneumaFlow™ Controller
provides significant reduction in electromechanical complexity and
vastly improved reliability compared to infusion pumps currently on
the market.
Beyond improvements to the underlying flow control technologies,
Pneuma is focused on addressing the unmet needs of clinicians and
patients who directly interact with these devices.
Safer, more reliable technology that measures both flow rate and
fluid volume offers opportunities to measurably improve fluid flow,
workflow, information flow, and cash flow.
About Pneuma
Pneuma Systems is a New
Hampshire based company founded by Jeffrey Carlisle, who also is the founder
of Ivenix, which was recently acquired by Fresenius. Pneuma is
dedicated to removing obstacles in the infusion therapy process
that interfere with a nurse's ability to care for the patient. More
information about Pneuma Systems is available
at www.pneuma-systems.com or at LinkedIn.
The Pneuma Systems Corporation 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.
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SOURCE Pneuma Systems Corporation