FDA Approves Medtronic’s CGM System for Type 2 Diabetes

Medtronic, CGM, type 2, diabetes, insulin, FDA, approvalAnother day, another Medtronic device.The US Food and Drug Administration (FDA) has approved the Ireland-based medical tech company’s Guardian Connect continuous glucose monitoring (GCM) system. The indication is Medtronic’s fifth this year, and seventeenth since 2017.

The CGM system is indicated for patients with diabetes aged 14-75 years old, and will serve as the first smart standalone system of its kind capable of keeping patients with diabetes ahead of high and low glucose events with alerts. Patients utilizing the device will also be to manage their diabetes with multiple daily injections.

The Guardian Connect alerts patients of impeding glucose events up to 1 hour in advance, through Medtronic’s predictive algorithms. In a clinical study testing the device’s efficacy, patients were accurately alerted to 98.5% of their hypoglycemic events. It improves on a field that, despite proven benefits, lacks a majority of patients using CGM systems, Timothy Bailey, MD, director of the AMCR Institute and clinical associate professor, University of California, San Diego, said in a statement.

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