FREESTYLE LIBRELINK APP FDA APPROVED

Where cutting-edge health tech meets every day needs. Now available in the U.S. for compatible iPhones.

FreeStyle LibreLink App FDA Approved

People with diabetes living in the U.S. and using the FreeStyle Libre or FreeStyle Libre 14 Day systems are now able to monitor their glucose directly on their compatible iPhones*.

The FreeStyle LibreLink app, now approved by the FDA, enables users to hold their iPhone near their FreeStyle Libre or FreeStyle Libre 14 Day sensor to instantly capture and view their real-time glucose levels, assess their eight-hour glucose history, and see a directional arrow indicating how their glucose is changing. FreeStyle LibreLink app also includes a series of in-app reports that visualize trends and patterns that help people understand how well they are controlling their glucose.

"We're committed to liberating people from the many hassles of diabetes management through our life-changing technology and tools," said Jared Watkin, senior vice president, Diabetes Care, Abbott. "The FreeStyle LibreLink app is a digital health tool that integrates glucose data directly on a compatible smartphone so all of the mobile apps that people use every day are in one convenient place. This is another step forward in making glucose monitoring seamlessly fit into a patient's daily lifestyle -- helping them live a fuller, healthier life."

FreeStyle LibreLink app will be free to download through the Apple App Store in the coming weeks. Once available, people will be able to pair the FreeStyle Libre or FreeStyle Libre 14 day sensors with the app. The Android version of the app is currently under development.

*The FreeStyle LibreLink app is compatible with NFC enabled phones on Apple’s iPhone 7 and later, running iOS 11 and later.

Indications and Important Safety Information

FreeStyle Libre and FreeStyle Libre 14 day Flash Glucose Monitoring systems are continuous glucose monitoring (CGM) devices indicated for replacing blood glucose testing and detecting trends and tracking patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments in persons (age 18 and older) with diabetes. The systems are intended for single patient use and require a prescription.

CONTRAINDICATIONS: Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment.

WARNINGS/LIMITATIONS: Do not ignore symptoms that may be due to low or high blood glucose, hypoglycemic unawareness, or dehydration. Check sensor glucose readings with a blood glucose meter when Check Blood Glucose symbol appears, when symptoms do not match system readings, or when readings are suspected to be inaccurate. The systems do not have alarms unless the sensor is scanned, and the systems contain small parts that may be dangerous if swallowed. The systems are not approved for pregnant women, persons on dialysis, or critically-ill population. Sensor placement is not approved for sites other than the back of the arm and standard precautions for transmission of blood borne pathogens should be taken. The built-in blood glucose meter is not for use on dehydrated, hypotensive, in shock, hyperglycemic-hyperosmolar state, with or without ketosis, neonates, critically-ill patients, or for diagnosis or screening of diabetes. When using FreeStyle LibreLink app, access to a blood glucose monitoring system is required as the app does not provide one. Review all product information before use or contact Abbott Toll Free (855-632-8658) or visit www.freestylelibre.us for detailed indications for use and safety information.

 

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