FDAnews
www.fdanews.com/articles/91232-medtronic-glucose-monitoring-devices-approved-for-children-teens

MEDTRONIC GLUCOSE MONITORING DEVICES APPROVED FOR CHILDREN, TEENS

March 13, 2007

The FDA has approved Medtronic's REAL-Time Continuous Glucose Monitoring devices for children and teenagers ages 7 to 17, the company announced.

The MiniMed Paradigm REAL-Time System and Guardian REAL-Time System were previously approved for adult patients but will soon be released in pediatric models.

Medtronic's REAL-Time therapy aids patients in monitoring and controlling their diabetes, reducing the duration of hypoglycemic events and lowering HbA1c levels by as much as 2 percentage points, the firm said, adding that diabetes management is especially difficult for pediatric patients.

The company currently markets the MiniMed Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring System. The Guardian REAL-Time System, a standalone continuous glucose-monitoring device, will be available later this year.