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FreeStyle Libre 3 gets FDA clearance opening the United States market for the world’s tiniest and most-accurate 14-day constant glucose screen

Abbott’s FreeStyle Libre ® 3 Receives U.S. FDA Clearance – Features World’s Smallest, Thinnest and Most Accurate 14- Day Glucose Sensor

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Abbott

May 31, 2022, 08: 00 ET

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The FreeStyle Libre 3 system is the most precise 14- day constant glucose monitor1, with readings sent out straight to a smart device every minute.2

Designed for gain access to and cost, the FreeStyle Libre 3 system will be offered at the very same cost as previous variations, which is one-third the expense of other completing constant glucose tracking systems offered today.3,4

ABBOTT PARK, Ill., May 31, 2022/ PRNewswire/– Abbott (NYSE: ABT) today revealed the U.S. Food and Drug Administration (FDA) cleared its next-generation FreeStyle Libre 3 system for usage by individuals 4 years and older6 living with diabetes.

” The FreeStyle Libre 3 system is a direct outcome of listening to our consumers– and providing the development and noticing innovation they’ve been searching for,” stated Jared Watkin, senior vice president of Abbott’s diabetes care organization. “It’s a video game changer for the countless individuals coping with diabetes. They’ll have the ability to handle their health minute-by-minute with the world’s tiniest and thinnest sensing unit and most precise 14- day constant glucose tracking system.”

FreeStyle Libre 3 System Features:

Greatest precision– with a 7.9% general indicate outright relative distinction (MARD), the FreeStyle Libre 3 system is the most precise 14- day constant glucose screen (CGM) with readings sent out straight to a smart device every minute.6 It’s the very first CGM to show a sub-8% MARD1,6– which is the basic method to determine constant glucose precision– the lower portion, the much better.

Smallest and thinnest– at the size of 2 stacked U.S. cents (used discreetly on the back of one’s arm), it’s the tiniest and thinnest4,7 CGM sensing unit on the planet.

Even simpler to utilize– with a one-piece applicator the sensing unit is straightforward to use.4

Strongest Bluetooth ® combination with a series of as much as 33 feet– 50% additional variety than other CGMs.4,8

Priced for Access and Affordability

Abbott will price the FreeStyle Libre 3 system the like previous versions9 with the objective of making it possible for the best variety of individuals dealing with diabetes to take advantage of the next-generation innovation.

” We continue to interfere with the idea that CGMs need to compromise quality or precision for price,” stated Watkin. “Access to advancement diabetes innovations must not run out grab individuals who can benefit most from them. Development for gain access to and cost is a core pillar in Abbott’s organization and sustainability technique.”

There is a large and growing requirement for brand-new developments in diabetes care. There are now more than 133 million Americans dealing with diabetes or prediabetes (almost half of the U.S. population), according to the American Diabetes Association.10 The company likewise keeps in mind that diabetes is the most typical underlying persistent condition in the U.S. and 1.4 million Americans aged 18 years or older are freshly identified with diabetes each year, which corresponds to one every 23 seconds.10

” I have actually seen real-world proof that diabetes innovations like CGMs have actually assisted my clients securely attain enhanced glycemic control,” stated Dr. Eugene E. Wright, Jr., seeking advice from partner at Duke University’s department of medication. “I praise Abbott for making their CGM system the most budget friendly and dealing with variations in care so clients dealing with diabetes can prevent problems and enhance their lifestyle.”

Digital Health Tools

The FreeStyle Libre 3 system was cleared for usage with the FreeStyle Libre 3 iOS and Android mobile apps, which allow users to see their glucose levels in genuine time, track their glucose history and patterns, and established optional alarms plus notices to assist them look out of major medical occasions like hypoglycemia.11

The mobile app incorporates with the FreeStyle Libre digital environment, consisting of LibreView and LibreLinkUp,12,13,14 allowing caretakers and health care specialists to from another location keep an eye on liked ones and clients as required.

Availability

The FreeStyle Libre 3 sensing unit will be readily available at taking part drug stores later on this year.15

Recognized Health Tech Innovator

Over the in 2015, the FreeStyle Libre 3 system has actually been acknowledged numerous times16 as a leading health tech development by:

Consumer Technology Association’s 2022 Consumer Electronics Show (CES) Best Health & & Wellness Innovation

The Edison 2022 Gold Award for Science & & Medical, Technology & Tools

Business Intelligence Group’s 2022 Healthcare Innovation Award

Medical Device and Diagnostic Industry’s 2022 Medical Design Excellence Bronze Award for Digital Health Products and Mobile Medical Apps; and

Lucintel’s 2021 Product Innovation Award in the Biosensors Market

The FreeStyle Libre portfolio is the most extensively utilized constant glucose tracking system in the U.S. and around the world and has actually altered the lives of around 4 million individuals throughout more than 60 nations.17 Abbott has actually protected partial or complete compensation for the FreeStyle Libre system in over 40 nations, consisting of Canada, France, Germany, Japan, the United Kingdom, and the U.S. 5 For more details check out FreeStyleLibre.com.

Indications and Important Safety Information

Failure to utilize FreeStyle Libre 3 system as advised in labeling might lead to missing out on an extreme low or high glucose occasion and/or making a treatment choice, leading to injury. If glucose alarms and readings do not match signs or expectations, utilize a fingerstick worth from a blood sugar meter for treatment choices. Look for medical attention when proper or contact Abbott at 855-632-8658 or FreeStyleLibre.us security details.

About Abbott is an international health care leader that assists individuals live more totally at all phases of life. Our portfolio of life-altering innovations covers the spectrum of health care, with leading companies and items in diagnostics, medical gadgets, nutritionals and top quality generic medications. Our 113,000 associates serve individuals in more than 160 nations.

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