Diality, a medical device company developing a smart, flexible hemodialysis platform, announced that it has secured 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its Moda-flx Hemodialysis System.
“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.
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“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).
SOURCE: Businesswire