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# Medtronic Gains Approval of Guardian Connect Glucose Monitor
- URL: https://www.fdaweb.com/medtronic-gains-approval-of-guardian-connect-glucose-monitor/
- Published: 2018-03-12T12:00:00.000Z
- Updated: 2026-09-14T23:29:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140961

FDA has approved a Medtronic PMA for its Guardian Connect continuous glucose monitoring (CGM) system for people with diabetes ages 14 to 75 years. The device is described by the company as the first smart standalone CGM system to help people with diabetes stay ahead of high and low glucose events. It says that the “Guardian Connect system is the only standalone CGM system that can alert patients of potential high or low glucose events up to 60 minutes in advance. Using Guardian Sensor 3, the most advanced glucose sensor from Medtronic and the only sensor trusted to power a hybrid closed loop system, the Guardian Connect system was proven in a clinical study to accurately alert patients of 98.5% of hypoglycemic events.”