US-based medical device company Diality has received the US Food and Drug Administration (FDA) 510(k) approval for its Moda-flx Hemodialysis System.
Moda-flx is a user-friendly, mobile, and connected haemodialysis platform that combines the capabilities of in-centre systems with the usability of next-gen haemodialysis devices.
It is designed to provide kidney care professionals with a broad range of variable flow rate ranges, integrated reverse osmosis water filtration, and an intuitive graphical user interface.
The Moda-flx system allows clinicians to customise each haemodialysis experience according to the patient’s requirements, on a unified, integrated platform.
The platform’s compact footprint and mobility will support the integration and transportation within dialysis care settings, said the medical device company.
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.”
The Moda-flx haemodialysis system is indicated for the treatment of patients with acute and chronic renal failure, regardless of their ultrafiltration status, at the point of care.
It offers treatment types including Intermittent Hemodialysis (IHD), Sustained Low-Efficiency Dialysis (SLED/SLEDD), and Prolonged Intermittent Renal Replacement Therapy (PIRRT).
The treatments must be administered by a trained staff who is deemed to be competent in the use of the device, under a physician’s prescription, said the medical device company.
Diality board member Allen Nissenson said: “Dialysis is an area of medicine long overdue for meaningful innovation.
“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.”
