US-based healthcare company Abbott has secured the US Food and Drug Administration (FDA) approval for its new-generation FreeStyle Libre 3 system.

The continuous glucose monitor was indicated for people living with diabetes, aged four years and above.

The current FDA approval follows the (Conformité Européenne) CE marking of the FreeStyle Libre 3 system granted in September 2020.

Abbott said that its FreeStyle Libre 3 system is a 14-day continuous glucose monitor (CGM) that transmits the readings directly to a smartphone, every minute.

The system features the world’s smallest and thinnest wearable glucose sensor and provides superior accuracy, with 7.9% overall mean absolute relative difference (MARD).

Abbott diabetes care business senior vice president Jared Watkin said: “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.

“It’s a game-changer for the millions of people living with diabetes. They’ll be able to manage their health minute-by-minute with the world’s smallest and thinnest sensor and most accurate 14-day continuous glucose monitoring system.

“We continue to disrupt the notion that CGMs have to sacrifice quality or accuracy for affordability. Access to breakthrough diabetes technologies should not be out of reach for the people who can benefit most from them. Innovation for access and affordability is a core pillar in Abbott’s business and sustainability strategy.”

The FreeStyle Libre 3 system is approved for use with the FreeStyle Libre 3 iOS and Android mobile apps.

With help of the apps, users can view their glucose levels in real-time, track their glucose history and trends, and set up optional alarms to get notified about serious medical events.

Also, the mobile app integrates with the FreeStyle Libre digital ecosystem, including LibreView and LibreLinkUp.

It enables the caregivers and healthcare professionals to remotely monitor the patients as per the requirement.

Abbott intends to commercialise its FreeStyle Libre 3 system through participating pharmacies, later this year.

The price of the FreeStyle Libre 3 system will be the same as previous versions, to enable more people with diabetes to benefit from the new-generation device, said the company.