2024-11-04

Quanta Dialysis Technologies Receives FDA Clearance for Home Dialysis System

Quanta Dialysis Technologies® has received FDA 510(k) clearance for its Quanta Dialysis System in the home setting, enabling high dialysate flow (500 mL/min) therapy for end-stage renal disease (ESRD) patients across all care settings.

“This clearance underscores our commitment to empowering patients with access to high-performance dialysis therapy at home,” said Alejandro Galindo, CEO of Quanta Dialysis Technologies. “Our system is designed to provide hospital-quality care in a convenient, user-friendly format, supporting better outcomes and greater independence.”

By addressing barriers to home hemodialysis (HHD)—currently accessed by only 2.4% of U.S. dialysis patients—Quanta’s innovative system offers a compact, versatile solution with demonstrated safety and efficacy in clinical trials. Over 90% of trial participants chose to continue using the device after the study.

For more information, visit www.quantadt.com.