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Senseonics receives FDA clearance for Eversense 365 CGM system

Senseonics Holdings announced that the U.S. Food and Drug Administration has cleared the next-generation Eversense 365 CGM system for people with Type 1 and Type 2 diabetes aged 18 years and older. Eversense 365 is the world’s first One Year CGM system, representing a significant breakthrough in diabetes technology and management. Ascensia expects to initiate the U.S. launch of Eversense 365 U.S. in the fourth quarter of 2024, with work ongoing to transition coverage availability in order to facilitate immediate access to as many users as possible.

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