Diality has announced the receipt of 510(k) clearance from the US Food & Drug Administration (FDA) for its Moda-flx haemodialysis system.
This system is designed to provide kidney care professionals with a range of variable flow rate ranges and integrated reverse osmosis water filtration, combined with a user-friendly graphical interface.
Diality CEO Osman Khawar said: “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.
“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.”
Moda-flx is built to offer clinicians the ability to tailor haemodialysis treatments to individual patient needs within one integrated system. Its compact design and portability facilitate easy integration and transport within various dialysis care environments.
Diality board member Dr Allen R Nissenson said: “Dialysis is an area of medicine long overdue for meaningful innovation.
“The Moda-flx haemodialysis 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.”
Last November, Diality disclosed its plans to conduct a clinical trial aimed at supporting a home-use indication for the Moda-flx.
The system is intended for use in patients suffering from acute and chronic renal failure, with or without ultrafiltration in an acute, post-acute, and chronic care facility.
The Moda-flx haemodialysis system supports a variety of treatment types including intermittent haemodialysis (IHD), sustained low-efficiency dialysis (SLED/SLEDD), and prolonged intermittent renal replacement therapy (PIRRT).
“Diality secures FDA 510(k) clearance for haemodialysis platform” was originally created and published by Medical Device Network, a GlobalData owned brand.
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