www.fdanews.com/articles/200156-baxters-remote-peritoneal-dialysis-system-gets-fda-ok
Baxter’s Remote Peritoneal Dialysis System Gets FDA OK
November 24, 2020
The FDA has granted Baxter 510(k) marketing clearance for Homechoice Claria, an automated peritoneal dialysis device that uses a remote patient management platform.
The system is cleared for both adult and pediatric patients and uses Sharesource, a two-way remote patient management service to enable patients to conduct dialysis treatments at home.
Claria provides on-screen dialysis instructions in 38 languages, as well as a web-based app that gives step-by-step, voice-activated instructions to direct the therapy.