Continuous Glucose Monitor From Senseonics Earns FDA Approval For ‘Non-Adjunctive’ Claim
Senseonics now can promote its Eversense continuous glucose monitoring system as a replacement for fingerstick testing to help patients make diabetes treatment decisions during the day, following FDA approval of a new non-adjunctive indication.
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Senseonics announced the long-awaited FDA approval of its Eversense E3 implantable CGM, featuring a sensor that lasts up to six months. The company is also developing a one-year version of Eversense and a transmitter-less version, but the stock market is disappointed with its sales projections.
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week’s approvals include the FDA’s approval of new non-adjunctive labeling for Senseonics’ Eversense continuous glucose monitor and a de novo for Innovative Health Solutions’ IB-Stim percutaneous electrical nerve field stimulator to treat pain associated with irritable bowel syndrome.
ADA 2019: Real-World Study Shows Abbott's FreeStyle Libre CGM Reduced HbA1c Levels In Type 2 Diabetics
At this year's annual American Diabetes Association (ADA) conference, Abbott presented real-world data from its FreeStyle Libre CGM suggesting it reduces HbA1c in type 2 diabetics. Look for more ADA coverage this week.