Abbott has received Food and Drug Administration (FDA) clearance for a reader for its newest continuous glucose monitoring (CGM) system in the USA.
Its FreeStyle Libre 3 system had received FDA clearance in May 2022, but at the time, monitoring could only be done through a smartphone, and Medicare reimbursement requires that devices must include a separate component, such as a reader, that is expected to last at least three years.
Abbott says that some 4.5m people in 60 countries use its FreeStyle Libre products to help manage their diabetes, making it the most widely used set of diabetes devices in the world. Now that its Libre 3 reader is cleared, the company said it is working to get the CGM added to Medicare’s list of covered systems “as soon as possible.”
Going forward, the Libre 3 system can work with a smartphone app or a separate reader.
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