We promise, we're not going to make too big of a deal of winning any award. But this news is definitely two BIG to keep quiet about.
The Business Intelligence Group (BIG) has named our BinaxNOW rapid COVID-19 test and our FreeStyle Libre 2 continuous glucose monitors among its 2021 BIG Innovation Awards.
Let's take these one at a time. First, BinaxNOW.
From our belief that COVID-19 testing should be more widely available, our BinaxNOW rapid test — the size of a credit card and requiring no instrumentation — received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for use at home with a prescription through a virtually guided online service.
The test provides results in minutes and detects the virus in the early part of the disease when people are most infectious, will be used with an online service, provided by eMed, which helps guide people through the testing process.
Next up: FreeStyle Libre 2.
For people living with diabetes — including Medicare patients who meet eligibility criteria1 — the FreeStyle Libre 2, an integrated continuous glucose monitoring (iCGM) system offers a lot more above and beyond its unsurpassed 14-day accuracy.2
It's the only iCGM that measures glucose every minute — five times more often than other CGMs3,4 — all while meeting the highest level of accuracy standards.5 Its alarms are optional, customizable and real-time, alerting you within a minute if you're too high or too low without having to scan.6
At 14 days, it's the longest-lasting iCGM available, nearly 40 percent longer7 than other iCGMs. You can trust in its reliability. And now it's available for kids 4 and up, broadening the impact of this revolutionary technology.
The 2021 BIG awards are honoring 52 companies and 137 products.
"Innovation is now critical for our civilization to progress," said Maria Jimenez, chief nominations officer of the Business Intelligence Group. "We are honored to award so many executives, companies and products the BIG Innovation award this year. Each person, company, and product has made tremendous strides at improving the lives of their community."
We share Jimenez's view about innovation's critical role in improving lives around the world. It's why we're working hard to make our technologies as affordable and accessible as we can.
For us, that's the biggest deal.
References
1 Patients must meet Medicare eligibility coverage criteria. Local Coverage Determination: Glucose Monitors (L33822), January 2020.
2 FreeStyle Libre 2 User Guide.
3 Data on file. Abbott Diabetes Care.
4Dexcom G6 CGM User Guide.
5 Based on FDA iCGM special controls.
6 Notifications will only be received when alarms are turned on and the sensor is within 20 feet of the reading device.
7 Based on comparison to Dexcom G6.
IMPORTANT SAFETY INFORMATION
BINAXNOW EMERGENCY USE AUTHORIZATION
The BinaxNOW™ COVID-19 Ag Card Home Test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
FREESTYLE LIBRE 2
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older.*
WARNINGS/LIMITATIONS:
The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment. Do not take high doses of vitamin C (more than 500 mg per day), as this may falsely raise your Sensor readings. Failure to use the System according to the instructions for use may result in missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value to make diabetes treatment decisions. Seek medical attention when appropriate and contact Abbott Toll Free (855-632-8658) or visit * www.freestylelibre.us for detailed indications for use and safety information.
*Please refer to www.freestylelibre.us for the indications and important safety information.
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