• 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 grants ALung EUA for respiratory assist system

FDA grants ALung EUA for respiratory assist system

April 24, 2020 By Sean Whooley

ALung TechnologiesALung Technologies announced today that it received FDA emergency use authorization (EUA) for its Hemolung respiratory assist system (RAS) for treating COVID-19.

Pittsburgh-based ALung said in a news release that it already treated numerous COVID-19 patients in the U.S. under existing FDA emergency use provisions, as well as in Europe, where it’s had CE Mark approval since 2013.

The Hemolung system is designed to use ECCO₂R therapy to allow carbon dioxide to be removed from the blood independently of the lungs in an effort to facilitate the avoidance or reduction of intubation and invasive mechanical ventilation, according to ALung’s website.

Hemolung is currently being used in the FDA-approved Vent-Avoid trial for studying ECCO2R for acute exacerbation of chronic obstructive pulmonary disease (AE-COPD). A United Kingdom trial with 412 patients that used Hemolung for acute respiratory distress syndrome (ARDS) recently concluded as well.

The FDA reviewed in vitro and in vivo information in support of ALung’s ongoing trial for Hemolung, along with clinical info from outside the U.S., to conclude that the system has the potential to treat lung failure as an adjunct to noninvasive or invasive mechanical ventilation to reduce hypercapnia and hypercapnic acidosis due to COVID-19.

Hemolung could also maintain levels of partial pressure of carbon dioxide and pH in patients suffering from acute, reversible respiratory failure due to COVID-19, according to a news release.

“We are pleased with the FDA’s recognition that the Hemolung may be beneficial in the treatment of COVID-19 by removal of CO2 directly from the blood during extracorporeal therapy,” ALung chairman & CEO Peter DeComo said in the release. “With published mortality rates as high as 90% for patients receiving invasive mechanical ventilation (IMV), we believe that the Hemolung can be a valuable tool for physicians to be used in conjunction with IMV, by reducing or eliminating the potential of further lung damage caused by high ventilator driving pressures, often referred to as ventilator-induced lung Injury (VILI).”

Filed Under: Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Respiratory Tagged With: ALung Technologies Inc., coronavirus, COVID-19, FDA

More recent news

  • A new way to monitor glucose: Glucotrack explains 3-year CBGM implant technology
  • Dexcom continues advances in AI for CGM, type 2 diabetes awareness
  • Tandem continues to deliver more options, benefits for those with diabetes
  • Breaking: Sequel to launch twiist automated insulin delivery system next month
  • Dexcom shares U.S. report on CGM benefits for type 2 diabetes

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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