• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » FDA clears NxStage Medical’s high-flow home hemodialysis

FDA clears NxStage Medical’s high-flow home hemodialysis

April 30, 2013 By Arezu Sarvestani

NxStage logo

NxStage Medical (NSDQ:NXTM) touted FDA clearance for high flow capabilities for the company’s System One home hemodialysis technology, a device the company calls the "only truly portable hemodialysis system cleared for home use."

The Lawrence, Mass.-based medical device maker plans to launch new higher flow System One devices later this year, according to a press release.

"This latest regulatory milestone reflects strong and systematic execution against our product pipeline," CEO Jeffrey Burbank said in prepared remarks. "With this new capability, NxStage therapy may be prescribed less frequently, for example 3 times per week or every other day, at treatment times consistent with those that patients and physicians experience in-center today."

"We’re strong believers in longer and more frequent dialysis for the clinical benefits," he added. "Still, high flow opens the NxStage solution more broadly to the patient segment that wants the benefits of home, but at in-center frequency."

NXTM shares got a boost on Wall Street today, trading 1.5% higher to $11.19 as of about 1:45 p.m.

Filed Under: 510(k), Dialysis, Food & Drug Administration (FDA), News Well Tagged With: Dialysis, NxStage Medical Inc.

More recent news

  • Autonomix picks up key nerve ablation catheter patent
  • Affluent Medical can move to pivotal phase of artificial urinary sphincter study
  • Globus Medical announces $500M share repurchase program
  • Cook Medical warns of issue with angiographic catheter
  • Virtuoso Surgical reports first cases with robotic endoscopy system, plans FDA IDE submission

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy