We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Baxter’s Remote Peritoneal Dialysis System Gets FDA OK

Baxter’s Remote Peritoneal Dialysis System Gets FDA OK

Baxter Logo
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.

View today's stories

Medical Devices Submissions and Approvals

Upcoming Events

  • 19Jan

    Pharmaceutical Quality Risk Management: Navigating the Intersection Between Regulatory Requirements & Risk Management

  • 21Jan

    Virtual MDSAP Audits in the Era of COVID-19: What to Know and Do to Pass Virtual Audits

  • 26Jan

    Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

  • 27Jan

    Medical Device Clinical Trials in China: Latest Regulatory Developments

  • 27Jan

    FDA’s Response to COVID-19: Fundamentals of Obtaining Emergency Use Authorizations

  • 09Feb

    Maintaining Your Risk-Based Cleaning and Disinfectant Programs: Best Practices During COVID-19

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Regeneron logo

    U.S. Government Orders More Supplies of Regeneron’s COVID-19 Antibody Cocktail

  • Siemens Healthineers logo

    Siemens Healthineers COVID Test Gets Additional Sampling Method Clearance

  • COVID-19  Clinical Trial

    Synairgen Initiates Dosing in Late-Stage Trial of Inhaled COVID-19 Therapy

  • Verona Pharma logo

    Verona Pharma Ends Enrollment in Inhaler-Administered COVID-19 Drug Pilot

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing