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Home » Senseonics expects FDA approval for next-gen 180-day CGM in ‘coming weeks’

Senseonics expects FDA approval for next-gen 180-day CGM in ‘coming weeks’

January 5, 2022 By Sean Whooley

Senseonics Eversense CGM
Senseonics’ Eversense continuous glucose monitor. (Image from Senseonics)

Senseonics (NYSE:SENS) announced that it anticipates the FDA to decide within weeks on approval of its new CGM system.

The company seeks 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. The next-generation Eversense matched 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.

Get the full story at our sister site, Drug Delivery Business News.

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), News Well, Patient Monitoring, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: CGM, FDA, Senseonics

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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