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Abbott’s FreeStyle Libre 3 Receives FDA Clearance

Abbott’s FreeStyle Libre 3 Receives FDA Clearance


In a major breakthrough for diabetes management, Abbott has received clearance from the US Food and Drug Administration (FDA) for its FreeStyle Libre 3 reader. The device features the world’s smallest glucose sensor, allowing people with diabetes to manage their condition by viewing real-time glucose readings on a handheld device. “The FreeStyle Libre 3 reader […]

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Posted On April 14, 2023
Abbott's FreeStyle Libre 3 Receives FDA Clearance

In a major breakthrough for diabetes management, Abbott has received clearance from the US Food and Drug Administration (FDA) for its FreeStyle Libre 3 reader. The device features the world’s smallest glucose sensor, allowing people with diabetes to manage their condition by viewing real-time glucose readings on a handheld device.

“The FreeStyle Libre 3 reader provides more choice to people living with diabetes to have access to lifesaving technology that is smaller and easier to use and comes without the high-cost burdens of other systems,” said Jared Watkin, senior vice president for Abbott’s diabetes care business.

The FreeStyle Libre 3 system has already changed the lives of 4.5 million people across more than 60 countries, making it the number one sensor-based glucose monitoring system in the world. With FDA clearance for its reader, Abbott is working to get the system added to Medicare’s list of covered systems as soon as possible.

The FreeStyle Libre 3 reader is a small handheld device that displays real-time glucose readings directly from a small sensor worn on the back of a person’s upper arm. The device has a large, bright, and easy-to-see screen, making it convenient for people to manage their diabetes quickly and easily.

“People who use the FreeStyle Libre 3 system will still have the option to use the current FreeStyle Libre 3 smartphone apps,” said Watkin.

The reader uses a rechargeable lithium-ion battery, which is commonly found in many other electronic devices like mobile phones. The user manual for the FreeStyle Libre 3 reader provides details on how to safely store, charge, and use the device, including always using the Abbott-provided USB cable and power adapter.

According to the Centers for Disease Control and Prevention (CDC), more than 34 million people in the United States have diabetes, and approximately 1.5 million Americans are diagnosed with the disease every year. Managing diabetes can be a challenging and expensive process, but Abbott’s FreeStyle Libre 3 system aims to make it easier and more affordable.

The FDA clearance for the FreeStyle Libre 3 reader is a significant milestone for Abbott, and it is expected to revolutionize the way people with diabetes manage their condition. The system’s small size, convenience, and affordability make it accessible to a larger population, ensuring that more people have access to lifesaving technology.

Abbott has been at the forefront of diabetes management for more than 70 years, and its FreeStyle Libre portfolio is a testament to the company’s commitment to innovation and patient care. The company is now working to expand the availability of its glucose monitoring system to more people with diabetes, and its efforts have been well-received by the medical community.

“The FreeStyle Libre 3 reader is a game-changer for diabetes management,” said Dr. Andrew Rhinehart, Chief Medical Officer at Glytec, a company that specializes in insulin management. “The small size, convenience, and accuracy of the sensor make it an excellent option for people with diabetes who want to take control of their health.”

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