Diality Receives FDA 510(k) Clearance for Its Moda-flx Hemodialysis System
2024年8月6日 - 8:15PM
ビジネスワイヤ(英語)
Patient-inspired technology designed to provide
ease of use and mobility for dialysis care
Diality, a medical device company developing a smart, flexible
hemodialysis platform, today announced that it has secured 510(k)
clearance from the U.S. Food & Drug Administration (FDA) for
its Moda-flx Hemodialysis System™.
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The Moda-flx Hemodialysis System™ from
Diality (Photo: Business Wire)
“Receiving 510(k) clinical clearance for Moda-flx is an
incredible milestone in our mission of developing solutions to
improve lives impacted by kidney disease,” said Osman Khawar, M.D.,
CEO of Diality. “We believe this platform will represent a new
paradigm in the treatment of kidney disease and will help reduce
the burden of care for all kidney care stakeholders.”
The Moda-flx Hemodialysis System is designed to empower kidney
care professionals with a wide range of variable flow rate ranges,
integrated reverse osmosis water filtration, and an intuitive,
easy-to-use graphical user interface. The Moda-flx Hemodialysis
System provides clinicians the flexibility to easily customize each
hemodialysis experience according to patient needs in one
integrated system. The platform’s compact footprint and mobility
enable integration and transportation within dialysis care
settings.
“Dialysis is an area of medicine long overdue for meaningful
innovation,” said Dr. Allen R. Nissenson, board member at Diality.
“The Moda-flx Hemodialysis System is a huge leap forward and
incorporates the right mix of clinical, technical and ease-of-use
characteristics to help dialysis providers thrive in today’s
challenging environment. I envision Moda-flx will create value for
patients and providers across multiple care settings where dialysis
is performed.”
The Moda-flx Hemodialysis System is indicated for use in
patients with acute and/or chronic renal failure, with or without
ultrafiltration, in an acute, post-acute, or chronic care facility.
Treatments must be administered under a physician’s prescription,
by a trained person who is considered competent in the use of the
device. Treatment types available include: Intermittent
Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/SLEDD),
and Prolonged Intermittent Renal Replacement Therapy (PIRRT).
About Diality
Diality is a medical device company focused on developing
solutions to improve lives impacted by kidney disease. The Moda-flx
Hemodialysis System is a user-friendly, mobile, and connected
hemodialysis platform designed to maximize clinical flexibility by
combining prescription capabilities of in-center systems with the
ease-of-use of next generation hemodialysis devices. Moda-flx
Hemodialysis system obtained U.S. FDA clearance in August 2024.
Please visit www.diality.com or find us on LinkedIn to learn more
about Diality and The Moda-flx Hemodialysis System™.
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version on businesswire.com: https://www.businesswire.com/news/home/20240806105630/en/
Sam Choinski Pazanga Health Communications
schoinski@pazangahealth.com (860) 301-5058