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MiniMed To File Home-Use Continuous Glucose Monitor PMA In Early 2000

This article was originally published in The Gray Sheet

Executive Summary

MiniMed is developing a follow-on version of its continuous glucose monitoring system (CGMS) that will be sold directly to patients, allowing them to monitor their own glucose levels, the firm said following FDA's June 16 approval of a non-consumer configuration as an adjunct to finger-stick blood glucose testing.

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Medtronic MiniMed's proposed labeling for the consumer version of its continuous glucose monitoring system (CGMS) "will not be as aggressive" as the firm originally planned, President Terry Gregg said Sept. 25 at an institutional investor conference in Minneapolis.

Medtronic MiniMed Consumer CGMS PMA Supplement To Be Refiled In Dec.

Medtronic MiniMed's proposed labeling for the consumer version of its continuous glucose monitoring system (CGMS) "will not be as aggressive" as the firm originally planned, President Terry Gregg said Sept. 25 at an institutional investor conference in Minneapolis.

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MiniMed's home-use continuous glucose monitoring system (CGMS) could be reviewed by FDA's Clinical Chemistry and Clinical Toxicology Panel as early as May 9, the company says.

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