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Medical Devices / Submissions and Approvals

Abbott Wins FDA Approval for First Pre-Calibrated Glucose Monitoring System

Oct. 4, 2017
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The FDA approved the first factory-calibrated personal continuous glucose monitor, manufactured by Abbott Diabetes Care.

Diabetic patients typically have to prick their fingers multiple times per day to test a blood sample or to calibrate their monitoring device. Abbott’s FreeStyle Libre Flash glucose monitoring system is the first device of its kind that does not require fingersticks for calibration or testing.

Users wear a sensor on their arm that can read glucose levels for up to 10 days.

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