Medtronic's Guardian Connect continuous glucose monitoring system receives FDA approval

Medtronic announced Monday that its Guardian Connect continuous glucose monitoring (CGM) system received FDA approval for use by people with diabetes aged 14 years to 75 years. Medtronic noted that the product is the "only standalone CGM system that can alert patients of potential high or low glucose events up to 60 minutes in advance."

Annette Brüls, president of Medtronic's diabetes service and solutions unit, remarked that "the FDA approval of the Guardian Connect system fills a key gap that exists in diabetes treatment today - how to predict dangerous glucose highs and lows so they can be potentially avoided." Brüls added that "with predictive alerts and the Sugar.IQ assistant, the Guardian Connect system enables people to proactively manage their diabetes."

According to Medtronic, the GCM system, which features Guardian Sensor 3, was proven in a clinical study to accurately alert patients of 98.5 percent of hypoglycaemic events.  Medtronic added that the system, which features Sugar.IQ smart diabetes assistant, developed with IBM Watson Health, continually analyses how an individual's glucose levels respond to several factors, such as food intake, insulin dosages and daily routines.

According to Medtronic, the GCM system, which received the CE mark in 2016 for use in people with diabetes using insulin injection therapy, will be launched in the US between May and July.

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