Diality announced today that it has secured 510(k) clearance from the US Food & Drug Administration (FDA) for its Moda-flx haemodialysis system. According to Diality’s press release, the Moda-flx haemodialysis 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. It also states that the Moda-flx also provides clinicians the flexibility to easily customise each haemodialysis experience according to patient needs in one integrated system. The platform’s compact footprint and mobility enable integration and transportation within dialysis care settings.
The Moda-flx haemodialysis 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 haemodialysis (IHD), sustained low efficiency dialysis (SLED/SLEDD), and prolonged intermittent renal replacement therapy (PIRRT).
“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, chief executive officer (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.”
“Dialysis is an area of medicine long overdue for meaningful innovation,” said Allen R. Nissenson, board member at Diality. “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.”
