• 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 » Abbott FreeStyle Libre 2 iCGM FDA cleared for use in adults and children

Abbott FreeStyle Libre 2 iCGM FDA cleared for use in adults and children

June 15, 2020 By Sean Whooley

AbbottAbbott (NYSE:ABT) announced today that it received FDA clearance for its FreeStyle Libre 2 system for adults and children ages four and older with diabetes.

The Abbott Park, Ill.-based company touts its FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system as the only such system with optional real-time alarms that measure glucose levels every minute over a 14-day wear time, making it long-lasting and eliminating the need for fingersticks.

FreeStyle Libre 2 uses Bluetooth to automatically alert users when glucose is high or low, removing the need to scan the sensor. Users can also turn off the customizable alarms, should they choose to. The system digitally connects and communicates with other compatible devices to allow for diabetes management to be specifically tailored to a person’s needs.

The sensor for the FreeSytle Libre 2 is worn on the back of the upper arm for 14 days and includes one-second scan capabilities with a handheld reader so users can see glucose readings, trends and eight-hour history. Abbott is also working to bring a compatible mobile app to the U.S. market, according to a news release.

Participating pharmacies and durable medical equipment suppliers in the U.S. will offer the FreeStyle Libre 2 system in the coming weeks at the same price as the currently available FreeStyle Libre 14-day system that has been on the market for nearly two years.

“We’re thrilled to bring our next generation technology on our world-leading sensing platform to both children and adults with diabetes in the U.S.,” Abbott senior VP of diabetes care Jared Watkin said in a news release. “With unsurpassed 14-day accuracy and enhanced features including optional alarms at a fraction of the cost of other CGMs, Abbott’s FreeStyle Libre 2 system will change the future of diabetes care in the U.S. the same way it has around the globe.”

Evercore ISI analyst Vijay Kumar told Reuters that the accuracy of data from Abbott’s FreeStyle Libre 2 looks better than that of its rival glucose monitor made by Dexcom (NSDQ:DXCM), and the FreeStyle Libre is priced significantly lower than Dexcom’s product, according to Kumar.

Although Abbott shares stood still in premarket trading and Dexcom shares dipped -1.4%, shares of ABT are now down -1.8% at $87.40 in mid-morning trading, while shares of DXCM are up 1.9% at $377.23.

Filed Under: Diabetes, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance Tagged With: Abbott, Dexcom, FDA

More recent news

  • Neuronetics names Steven Pfanstiel chief financial officer
  • Medtronic to distribute Future Medical’s peripheral guidewires
  • AtriCure completes enrollment in stroke prevention trial
  • GT Medical raises $53M to support brain tumor treatment
  • Imperative Care, Proximie partner to develop surgical robot to treat stroke

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