Beverly, Massachusetts–based Quanta said in a news release that the FDA nod makes it the only company offering a high dialysate flow (500 mL/min) system across the entire care continuum for end-stage renal disease (ESRD) patients.

The company says its clearance marks a significant step in its U.S. commercialization efforts. It comes on the heels of clearance for its device for performing intermittent hemodialysis (IHD), sustained low-efficiency dialysis (SLED), and CRRT (CVVHD and SCUF) without any need for bags.