FDA Clears Quanta Dialysis System for Home Hemodialysis

The US Food and Drug Administration (FDA) has given 510(k) clearance to Quanta Dialysis Technologies for the use of its Quanta Dialysis System in the home setting.

Quanta is the only company to offer a high dialysate flow (500 mL/min) system across the entire care continuum for end-stage renal disease patients. The company previously received FDA clearance for the first device able to perform intermittent hemodialysis, sustained low-efficiency dialysis, and continuous renal replacement therapy (continuous venovenous hemodialysis and slow continuous ultrafiltration) without the need for bags.

Of approximately 550,000 prevalent ESRD patients receiving dialysis in the United States, only 2.4% receive home hemodialysis. The Quanta Dialysis System aims to address this gap by giving patients access to a high-flow system at home, similar to what is routinely offered in hospitals, post-acute facilities, and in-center clinics.