Simergent Secures Breakthrough FDA Clearance for Archimedes™ Home Dialysis System

Simergent, a company focused on improving treatment for kidney failure, has announced that its Archimedes™ automated peritoneal dialysis (APD) system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). 

The system is designed for patients with End Stage Kidney Disease (ESKD) and can be used in both home and clinical settings.

Archimedes™ offers a user-friendly interface suitable for patients and clinic staff with diverse backgrounds. It operates quietly without a pump, has a four-hour battery life, and features an integrated mobile cart to allow in-home mobility during therapy. 

The system also uses a patented shroud for safe tubing and bag connections and can be set up in just five minutes, reducing waiting time before treatment.

Following a successful usability study at Northwestern University and Indiana University, Simergent plans to launch Archimedes™ in the U.S. in 2026. 

The device aims to make home dialysis more flexible and accessible, offering patients greater independence and clinicians a simpler, safer treatment option.