Diality received FDA 510(k) clearance for its Moda-flx smart, flexible hemodialysis system. California–based Diality designed the system to provide 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 provides clinicians with the flexibility to easily customize each hemodialysis experience according to patient needs in one integrated system.
Related: Teleflex scoops FDA 510(k) clearance for interventional cardiology catheter
Diality said it aims for the system’s compact footprint and mobility to enable integration and transportation within dialysis care settings.
The FDA cleared Moda-flx for patients with acute and/or chronic renal failure. Its indication covers treatment with or without ultrafiltration in an acute, post-acute or chronic care facility. Treatments require administration under a physician’s prescription, by a trained person considered competent in the use of the device. Treatment types include intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED/SLEDD) and prolonged intermittent renal replacement therapy (PIRRT).
Diality board member Dr. Allen R. Nissenson said Moda-flx represents a “huge leap forward.” Nissenson said it “incorporates the right mix of clinical, technical and ease-of-use characteristics.”
“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 Dr. Osman Khawar, 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.”
