Life Science News

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. 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.
  3. 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.
  4. Data on file, Abbott Diabetes Care.

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)
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
Avisa Diagnostics Begins Trading on the Canadian Securities Exchange

Avisa Diagnostics Begins Trading on the Canadian Securities Exchange

  • Public Listing offers Access to CAD 52 Million from Share Subscription and Drawdown Agreement, Sufficient Funding to Complete Development and Launch Avisa BreathTest™
  • Pivotal Trials Planned in Post-COVID-19 Long Haulers and Ventilator-Associated Pneumonia

Avisa Diagnostics Inc. (Avisa) is pleased to announce that the Company has begun trading on the Canadian Securites Exchange (CSE:AVBT) through the previously announced merger completion with Fogchain Corp. Avisa has developed the Avisa BreathTest™ (ABT), an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of bacterial load in Post-COVID-19 “long haulers,” who can develop acute respiratory disease, and ventilator-associated pneumonia (VAP), an indication with high morbidity and mortality.

The public listing enables Avisa to draw down over the period of three years CAD 52 million (~USD 41 million) from a share subscription and drawdown agreement put in place in 2020 with GEM GLOBAL YIELD LLC SCS (GEM), a $3.4 billion alternative investment group with offices in Paris, New York, and Los Angeles.

Keep reading...Show less
abt stock

Avisa Diagnostics Begins Trading on the Canadian Securities Exchange

  • Public Listing offers Access to CAD 52 Million from Share Subscription and Drawdown Agreement, Sufficient Funding to Complete Development and Launch Avisa BreathTest™
  • Pivotal Trials Planned in Post-COVID-19 Long Haulers and Ventilator-Associated Pneumonia

Avisa Diagnostics Inc. (Avisa) is pleased to announce that the Company has begun trading on the Canadian Securites Exchange (CSE:AVBT) through the previously announced merger completion with Fogchain Corp. Avisa has developed the Avisa BreathTest™ (ABT), an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of bacterial load in Post-COVID-19 "long haulers," who can develop acute respiratory disease, and ventilator-associated pneumonia (VAP), an indication with high morbidity and mortality.

The public listing enables Avisa to draw down over the period of three years CAD 52 million (~USD 41 million) from a share subscription and drawdown agreement put in place in 2020 with GEM GLOBAL YIELD LLC SCS (GEM), a $3.4 billion alternative investment group with offices in Paris, New York, and Los Angeles.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Aehr Test Systems Receives Orders of Over $2.3 million

Aehr Test Systems (NASDAQ:AEHR) has over 2,500 systems installed over the world that test optical and memory integrated circuits, semiconductors and reliability qualification equipment announced that it received over $2.3 million in orders for test and burn-in services. These orders came from a major manufacturer where Aehr’s services would be implemented for automotive products.

As quoted in the press release:

Keep reading...Show less

Cyclacel Reports Fourth Quarter And 2016 Financial Results

Cyclacel Pharmaceuticals (NASDAQ:CYCC) posted its financial results for the fourth quarter and full year 2016.
As quoted in the press release:

The Company’s net loss applicable to common shareholders for the three months and year ended December 31, 2016 was $2.9 million and $12.0 million, respectively. As of December 31, 2016, cash and cash equivalents totaled $16.5 million.

Keep reading...Show less

InspireMD Announces Promotion of Andrea Tommasoli to Chief Operating Officer

InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it has promoted Andrea Tommasoli to Chief Operating Officer. Mr. Tommasoli formerly served as the Company's Senior Vice President of Global Sales & Marketing since joining InspireMD in November 2020.

"Andrea has been instrumental in expanding the footprint of CGuard EPS across our approved markets in the EU and, as we advance toward potential U.S. approval with our ongoing U.S. Investigational Device Exemption (IDE) clinical trial, and as our business requirements shift toward operational capacity to support our commercial growth, we believe his background and skill set make him an ideal candidate to assume the role of Chief Operating Officer of the Company at this important time," stated Marvin Slosman, Chief Executive Officer of InspireMD. "On behalf of the entire InspireMD team, I would like to congratulate Andrea on this promotion and look forward to his continued contributions."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

GeminiBio Appoints Industry Veteran Cory Stevenson as Executive Chairman

Gemini BioProducts Holding, Inc. ("GeminiBio" or the "Company"), a portfolio company of BelHealth Investment Partners, LLC ("BelHealth"), a Florida -based healthcare private equity firm, announced the appointment of Cory Stevenson as Executive Chairman of the Board of Directors.

(PRNewsfoto/BelHealth Investment Partners)

Mr. Stevenson joined the Board of GeminiBio in 2022 and has been working closely with the GeminiBio management team as they prepare to complete a three-phase buildout that addresses the long-term capacity needs in the biopharma and cell/gene therapy marketplace. Previously, Mr. Stevenson served as President of the BioProduction Division of Thermo Fisher Scientific (NYSE:TMO), a world leader in serving the biopharma sector, with annual revenue of more than $40 billion . During Cory's tenure, the BioProduction business grew from $200 million in revenues to over $2.5 billion annually.

Harold S. Blue , Managing Partner of BelHealth Investment Partners said, "We are fortunate to have Cory expand his role and guide our strategy at GeminiBio. Cory has been very helpful during the last year as a board member and I am excited that he will be taking a more active role. Also, given that Cory worked directly with GeminiBio's CEO, Brian Parker , while at Thermo Fisher, this was a natural fit."

Cory Stevenson , Executive Chairman of GeminiBio added, "I am delighted to expand my role at GeminiBio after working closely with Brian and the rest of the team since I joined the Board. With the completion of its 57,000-square-foot manufacturing facilities, GeminiBio is positioning itself as a vendor delivering much-needed critical solutions to the global biopharma industry. I am looking forward to this exciting next phase at GeminiBio."

About BelHealth Investment Partners

BelHealth Investment Partners, based in Fort Lauderdale, Florida , is a healthcare private equity firm focused on lower middle market companies. BelHealth has a unique combination of investing, executive management, and entrepreneurial experience. BelHealth acquires majority positions in entrepreneur-owned companies that it believes will benefit from its extensive operating and private equity investment expertise. For more information, visit www.belhealth.com .

About GeminiBio

Founded in 1985, GeminiBio serves the global biotechnology industry, from basic research to commercial production, with a focus on helping our customers accelerate the development of life enhancing biotherapeutics by streamlining and improving their cell culture and process liquid manufacturing workflows. The company's products are organized into two core verticals – Cell Culture Solutions and Process Liquid Solutions. Located in West Sacramento, California , GeminiBio has 57,000 square feet of cGMP manufacturing space that is segregated between animal origin free and animal component manufacturing. GeminiBio is an ISO 13485 certified, FDA registered Class 1 Medical Device Manufacturer, aligned with 21 CFR Part 820. For more information, visit www.geminibio.com .

Contact:
BelHealth: Inder Tallur , itallur@belhealth.com
GeminiBio: bparker@geminibio.com

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/geminibio-appoints-industry-veteran-cory-stevenson-as-executive-chairman-301774586.html

SOURCE BelHealth Investment Partners

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Notice of Knight Therapeutics' Fourth Quarter and Year End 2022 Results Conference Call

Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a leading pan-American (ex-USA) specialty pharmaceutical company, will release its fourth quarter and year end 2022 financial results on Thursday, March 23, 2023 prior to market opening. Following the release, Knight will hold a conference call and audio webcast. Knight cordially invites all interested parties to participate in this call.

Date : Thursday, March 23, 2023

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Janssen Announces Novel Dengue Antiviral Demonstrates Efficacy in Pre-Clinical Data Published in Nature

The antiviral is efficacious in non-human primates, and is safe and well-tolerated in humans

Findings support further clinical development for prevention and treatment of dengue, which impacts millions of people today and is poised to threaten many more due to climate change

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Medtronic receives CE Mark approval for Affera Mapping and Ablation System to treat atrial arrhythmias

First of its kind, all-in-one Sphere-9™ Catheter with pulsed field ablation, radiofrequency, and high density mapping integrated with intuitive mapping and navigation platform

Medtronic (NYSE:MDT) announced today that it has received CE ( Conformité Européenne ) Mark for the Affera™ Mapping and Ablation System, which includes the Sphere-9™ Catheter and the Affera™ Prism-1 Mapping Software. Together, the full system creates a new paradigm in electrophysiology through the unique integration of the Sphere-9 pulsed field ablation (PFA), radiofrequency (RF), and high density (HD) mapping catheter, which maps and ablates atrial arrhythmias (fast, abnormal heart rhythms) and provides real-time feedback through its intuitive mapping and navigation software. Atrial fibrillation (AFib) is the most common atrial arrhythmia, and nearly 60 million people are affected worldwide 1 and five million patients will be added every year by 2030 2 . Atrial arrhythmias, such as AFib, are associated with serious complications including heart failure, stroke and increased risk of death 3-6 .

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Medtronic named one of World's Most Ethical Companies

Recognition honors companies demonstrating business integrity through best-in-class ethics, compliance, and governance practices

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, has been recognized by Ethisphere, a leader in defining and advancing the standards of ethical business practices, as one of the 2023 World's Most Ethical Companies . In 2023, 135 honorees were recognized spanning 19 countries and 46 industries. Medtronic is one of only two honorees in the 'Healthcare Products' industry category.

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×