Senseonics (NYSE:SENS) announced that it anticipates a decision from the FDA regarding the approval of its new CGM system within weeks.
The company is seeking a premarket approval supplement for the next-generation Eversense 180-day implantable continuous glucose monitoring (CGM) system. Data presented earlier this year demonstrated strong accuracy, with the next-generation Eversense matching performance levels compared to the current 90-day sensor available in the U.S., but with reduced calibration, down to one per day, with the duration extended to 180 days.
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