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What you need to know about continuous glucose monitors following the FDA's approval of the first over-the-counter device. ... For diabetics, this often requires management through insulin therapy.
When the FDA approved the first CGM in 1999, CGMs were meant to help people with all types of diabetes track their blood sugar levels. Unlike traditional home glucose meters, like a fingerstick or ...
The Food and Drug Administration's clearance for Libre Rio allows access to a continuous glucose monitor for 24.5 million type 2 diabetes patients who do not use insulin, RBC Capital Markets ...
Dexcom entered a non-exclusive agreement with Tandem Diabetes Care, Inc. in 2015 to allow the integration of its forthcoming G5 and G6 continuous glucose monitoring systems into Tandem's insulin pumps. [8] The G5 was approved in 2016 by the FDA for use as a standalone device, while the G6 gained approval in 2018. [9]
In June 2018, the FDA approved the Eversense CGM system (manufactured by Senseonics Inc) for use in people 18 years of age and older with diabetes. This is the first FDA-approved CGM to include a fully implantable sensor to detect glucose, which can be worn for up to 90 days.
The agency's notice doesn't apply to smartwatch apps linked to sensors, such as continuous glucose monitoring systems that measure blood sugar directly. Roughly 37 million Americans have diabetes .
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