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Senseonics' Eversense XL
Graphic by Amanda Pedersen/MD+DI
Senseonics expects to receive approval for its Eversense 180-day pre-market approval supplement by the end of the year. The company submitted the PMA supplement in October 2020.
The PMA supplement application is being supported by soon-to-be published data from the PROMISE study. The submission was assigned to a lead FDA reviewer on April 15.
If approved, the continuous glucose monitor (CGM) would be approved for 180 days of use, as opposed to the current 90-day indication.
