Diality’s Moda-flx Hemodialysis System Gets FDA 510(k) Clearance

Medical device maker Diality announced that Moda-flx, its flexible hemodialysis system, has received 510(k) clearance from the US Food and Drug Administration (FDA).

The Moda-flx Hemodialysis System gives clinicians the flexibility to easily customize the hemodialysis experience. The platform features a wide range of variable flow rate ranges, integrated reverse osmosis water filtration, and an easy-to-use graphical interface. Moda-flx is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute, postacute, or chronic care facility.

“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, MD, chief executive officer 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.”

Section 510(k) of the Food, Drug, and Cosmetic Act requires device manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance; this step is known as premarket notification. Medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected.