U.S. FDA Clears Abbott's FreeStyle Libre® 2 and FreeStyle Libre® 3 Sensors for Integration with Automated Insulin Delivery Systems

 
 
  • Abbott's world's leading 1 and affordable 2 integrated continuous glucose monitoring (iCGM) sensors are cleared for connectivity with automated insulin delivery (AID) systems in the U.S.
  •  
  • Sensors also cleared for use by children as young as two years old, for use by women with diabetes who are pregnant, and for wear time up to 15 days
  •  

- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has cleared its FreeStyle Libre 2 and FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system sensors for integration with automated insulin delivery (AID) systems. Abbott modified the sensors to enable integration with AID systems.

 
 

  Abbott's FreeStyle Libre 2 iCGM system 

 
 

"Our goal is to make diabetes care as easy as possible," said Jared Watkin , senior vice president for Abbott's diabetes care business. "The FreeStyle Libre portfolio is already the most prescribed CGM in the United States³ and, with the integration of automated insulin delivery systems, people in the U.S. will soon have an affordable 2 option to pair with insulin pumps. This means less time thinking about diabetes and more time living."

 

AID systems help people manage daily diabetes care by automatically adjusting and administering the insulin delivered by an insulin pump based on real-time glucose data from their FreeStyle Libre 2 or FreeStyle Libre 3 sensors.

 

Abbott is working with leading insulin pump manufacturers to integrate their systems with the FreeStyle Libre 2 and FreeStyle Libre 3 sensors as soon as possible. The company is partnering with Insulet and Tandem for future integrations in multiple countries, including the U.S. Outside the U.S., Abbott's FreeStyle Libre 3 sensor is already authorized to work with the mylife™ Loop solution from Ypsomed and CamDiab in Germany , with additional launches in the UK, Switzerland and the Netherlands planned for the first half of this year.

 

The modified sensors were also cleared for use by children as young as two years old and for wear time up to 15 days. Current FreeStyle Libre 2 and FreeStyle Libre 3 sensors available today in the U.S. are approved for people four years and older and have a wear time of up to 14 days.

 

Additionally, the clearance allows for FreeStyle Libre 2 and FreeStyle Libre 3 sensors – both those available today and the modified sensors available in the future – to be used by women with all types of diabetes (Type 1, Type 2 and gestational) who are pregnant.

 

The modified FreeStyle Libre 2 and FreeStyle Libre 3 sensors will be available in the U.S. later this year. Over time, the modified sensors will replace the current FreeStyle Libre 2 and FreeStyle Libre 3 sensors available today in the U.S.

 

The FreeStyle Libre portfolio is the number one sensor-based glucose monitoring system in the world 1 , having changed the lives of 4.5 million people across more than 60 countries 4 by providing breakthrough technology that is accessible and affordable. 2

 

  Important Safety Information
Failure to use FreeStyle Libre 2 or FreeStyle Libre 3 systems as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If glucose alarms and readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or FreeStyleLibre.us safety info.

 

  About Abbott  
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

 

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott- , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews .

 
  1. Data based on the number of users worldwide for FreeStyle Libre family of personal CGMs compared to the number of users for other leading personal CGM brands and based on CGM sales dollars compared to other leading personal CGM brands.
  2.  
  3. Based on a comparison of list prices of the FreeStyle Libre 2 and FreeStyle Libre 3 systems versus competitors' CGM systems, assuming annual use of one receiver (or equivalent hardware) and quantity of transmitters and/or sensors according to use life. The actual cost to patients may or may not be lower than other CGM systems, depending on the amount covered by insurance, if any.
  4.  
  5. Data on file, Abbott Diabetes Care. Based on the number of patients assigned to each manufacturer based on last filed prescription in US Retail Pharmacy and DME.
  6.  
  7. Data on file, Abbott Diabetes Care.
  8.  

 

 
 

  Abbott's FreeStyle Libre 3 iCGM system 

 

  Abbott Logo (PRNewsFoto/Abbott) 

 
 

 Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/us-fda-clears-abbotts-freestyle-libre-2-and-freestyle-libre-3-sensors-for-integration-with-automated-insulin-delivery-systems-301763020.html  

 

SOURCE Abbott

 
 

News Provided by PR Newswire via QuoteMedia

ABT
The Conversation (0)
Abbott Announces New Partnerships and Programs to Advance its Diversity in Clinical Trials Initiative

Abbott Announces New Partnerships and Programs to Advance its Diversity in Clinical Trials Initiative

 
 
  • New efforts focus on research infrastructure, continued training of diverse clinical research personnel and improved diversity within Abbott's own clinical trials
  •  
  • Abbott's Diversity in Clinical Trials initiative aligns with the company's continued focus for greater health equity, expanded access, affordability and removing barriers to life-saving technology and innovation
  •  
  • The new programs build on a successful first year of the multi-million-dollar corporate initiative
  •  

Abbott (NYSE: ABT) today announced a series of new programs within its multi-million-dollar initiative to increase diversity in clinical trials and improve care among under-represented populations. The new additions to Abbott's Diversity in Clinical Trials initiative build on the partnerships, scholarships, and the focus on diversified participants in the company's own clinical trials during the initiative's first year.

 

The latest programs include the launch of a new initiative with the Norton Healthcare Foundation to build and implement new models of sustainable clinical research alongside the Institute for Health Equity, a Part of Norton Healthcare in Louisville, Ky. ; a new training program for clinical research coordinators in partnership with Barnett International; and a newly-created Diversity in Research Office at Abbott focused on ensuring diverse representation in clinical trials.

 

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
richard murray md

Avisa Diagnostics Appoints Dr. Richard Murray as Chief Medical Officer

 

Avisa Diagnostics Inc. (CSE:AVBT) (Avisa), a clinical-stage medical device company developing an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of virulent bacterial lung infections, is pleased to announce that the Company has hired Richard K. Murray, M.D., to the newly created position of Chief Medical Officer (CMO).

 

Dr. Murray has over 25 years of industry experience. He worked at Merck & Co. for many years in positions of increasing responsibility, in a variety of business, medical and scientific areas. His most recent position was Vice President and Deputy Chief Patient Officer. Dr. Murray was also a Fellow at the Advanced Leadership Initiative at Harvard University. He has managed all areas of medical affairs, including outcomes research, medical information, professional and academic affairs, field-based medical physicians, and investigator-initiated trials globally. Prior to his industry career, he was a practicing physician in cardiovascular-pulmonary medicine and an asthma researcher at the Hospital of the University of Pennsylvania. Dr. Murray has an M.D. from Howard University and an M.A. in Chemistry and A.B. in Psychology from Clark University. Dr. Murray currently is Board Chair of the Asthma and Allergy Foundation of America.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
illustration of brain and cell phone.

BlinkLab Completes First Patient Test for US Autism Diagnostic Study

Digital healthcare company BlinkLab (ASX:BB1) has tested the first patient in its US autism diagnostic study, which is geared at validating the company's Dx1 test as a diagnostic aid for clinicians.

BlinkLab states in its Wednesday (March 12) release that the study is the largest digital diagnostic trial for autism in the US, with its aim being to support the early detection of developmental conditions like autism.

The first patient test took place at PriMED Clinical Research in Dayton, Ohio. PriMED, a division of PriMED Physicians, is one of two clinical sites selected for the study’s initial phase, which is targeting 100 patients.

Keep reading...Show less
HeraMED Signs Strategic Collaboration Agreement with Garmin Health

HeraMED Signs Strategic Collaboration Agreement with Garmin Health

HeraMED Limited (ASX: HMD), a medical data and technology company leading the digital transformation of maternity care, is delighted to announce it has entered into a collaboration agreement with Garmin (NYSE: GRMN), a leading global provider of smartwatches and GPS-enabled products, aimed at enhancing remote pregnancy monitoring and expanding the range of health data available to expectant mothers and their healthcare providers.

Keep reading...Show less
Cardiologist wearing virtual reality glasses.

2 Biggest Medical Device ETFs in 2025

Exchange-traded funds (ETFs) are a popular investment strategy, and generally contain a variety of publicly traded companies under one stock symbol, often with a focus on a specific sector.

Depending on the ETF, investors may be able to track up-and-coming companies, get exposure to top firms or a mix of both. Aside from stocks, some ETFs also track commodities or bonds.

In the healthcare industry, medical device ETFs bring together companies that go to great lengths to develop pharmaceutical-based technology that can improve the lives of patients.

Keep reading...Show less
Cyclomedica

Cyclopharm Signs US Agreement with HCA Healthcare for Technegas®

Cyclopharm Limited (ASX: CYC) is pleased to announce the signing of a major contract with Hospital Corporation of America Healthcare (HCA), one of the largest single healthcare providers in the United States. This agreement marks a significant milestone for the company which will allow the deployment of Technegas® in up to 169 nuclear medicine departments across HCA’s extensive network.1

Keep reading...Show less
CONNEQT App Launches in USA as Pulse Deliveries Commence

CONNEQT App Launches in USA as Pulse Deliveries Commence

Cardiex Limited (CDX:AU) has announced CONNEQT App Launches in USA as Pulse Deliveries Commence

Download the PDF here.

Female doctor with clipboard talking to smiling female patient at hospital.

Revolutionizing Women's Health: Antifungal Innovation Brings New Investment Opportunities

The intersection of women's health and antifungal innovation represents a pivotal moment in healthcare, offering both transformative medical advancements and compelling investment opportunities.

The groundbreaking developments in antifungal treatments specifically targeting women's health issues present a substantial market potential, resulting in rising investor interest in this rapidly evolving sector.

Despite comprising half the global population, women face unique health challenges that have historically received insufficient attention and investment. Among these health challenges, vaginal candidiasis stands out as a persistent and widespread issue affecting millions of women worldwide.

Keep reading...Show less

Latest Press Releases

Related News

×