Tag: Abbott

ABBOTT PARK, Ill. – Abbott has received clearance from the U.S. Food and Drug Administration (FDA) for a reader for its FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system, which features a small, thin and discreet glucose sensor. With the FDA's clearance of a standalone reader, Abbott is working to get the FreeStyle Libre 3 system added to Medicare's list of covered systems as soon as possible. "Our customers all over the world consistently tell us how our FreeStyle...

ABBOTT PARK, Ill. – Abbott in February initiated a voluntary medical device correction for its FreeStyle Libre, FreeStyle Libre 14 day and FreeStyle Libre 2 readers in the United States due to a limited number of reports (0.0017%) over several years of their lithium-ion batteries swelling, infrequently overheating or, in very rare cases, sparking or catching fire. No readers are being physically recalled and customers can continue to use their readers with the Abbott-provided USB cable and...

FALLS CHURCH, Va. – The TRICARE pharmacy benefit now covers two brands of continuous glucose monitors (CGMs): the Abbott FreeStyle Libre 2 and the Dexcom G6. Previously, CGMs were only available as DME under the TRICARE medical benefit. They will also continue to be covered under the medical benefit. “This change in expanded coverage will improve access for patients to get the CGMs they need,” said Edward VonBerg, PharmD, chief of the Defense Health Agency’s Formulary Management...

ABBOTT PARK, Ill. – Abbott has received clearance from the U.S. Food and Drug Administration for its FreeStyle Libre 3 system for people with diabetes age four and up. "The FreeStyle Libre 3 system is a direct result of listening to our customers – and giving them the innovation and sensing technology they've been looking for," said Jared Watkin, senior vice president of Abbott's diabetes care business. "It's a game changer for the millions of people living with diabetes....

ABBOTT PARK, Ill. – Abbott has received approval from the Japanese Ministry of Health, Labour and Welfare for expansion of reimbursement coverage for its FreeStyle Libre system to include all people with diabetes who use insulin at least once a day. The expanded coverage will enable more people with diabetes to access the glucose data needed to manage their condition without the routine fingersticks associated with traditional blood glucose monitoring. "The best health care solution is the...

ABBOTT PARK, Ill. - Abbott has received Food and Drug Administration clearance for its Freestyle Libre 2. The Libre 2 continuously transmits glucose data every minute, and users can set the system to send alarms for too-high or too-low readings. Previously, users had to scan the sensor to get a reading. The system, which is offered at the same price point as the previous version of the Freestyle Libre, will become available in the next several weeks. The FreeStyle Libre was approved for Medicare...

One Drop has announced the results of a study demonstrating a -0.93 absolute A1c improvement among people with Type 2 diabetes who use its digital therapeutic solution and Afrezza, an inhaled insulin. What's more, A1c improved with the One Drop solution—One Drop Mobile app, One Drop Chrome glucose meter and testing supplies and One Drop Experts coaching—regardless of what type of insulin was used, according to outcomes presented at the 2019 Advanced Technologies & Treatments for Diabetes...

ABBOTT PARK, Ill. - Abbott and Novo Nordisk have partnered to integrate insulin dose data from Novo Nordisk's connected insulin pens with digital health tools compatible with Abbot's FreeStyle Libre continuous glucose monitoring system. The integration will allow healthcare professionals, caregivers and patients to view glucose and insulin data together to help them make better informed treatment decisions, according to a press release. "It is our aim at Abbott to continuously provide life-changing...

ABBOTT PARK, Ill. - The FreeStyle LibreLink app has been approved by the U.S. Food and Drug Administration for the iPhone, according to a press release from Abbott. The app allows user to capture and view real-time glucose levels. It also includes a series of in-app reports that visualize blood glucose trends and patterns. The free app will be available for download in the coming weeks and will be able to pair with the FreeStyle Libre or FreeStyle Libre 14 day sensors. The Android version is currently...

ABBOTT PARK, Ill. - The U.S. Food and Drug Administration has approved Abbott's FreeStyle Libre 14-day Flash Glucose Monitoring System. The system has a one-hour warm-up period, compared to 12 hours with the FreeStyle Libre 10-day system, which received FDA approval in September 2017. The Libre is the No. 1 continuous glucose monitoring device in the world, with more than 800,000 users in more than 43 countries, according to a press release. It was approved for Medicare coverage in January.