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MiniMed to submit 510(k) for continuous glucose monitor by year-end, company tells analysts.

This article was originally published in The Gray Sheet

Executive Summary

MINIMED CONTINUOUS GLUCOSE MONITORING SENSOR TRIALS IN "FINAL STAGES" and anticipated to be complete by the end of the year, the company says. A four-site, 60-patient pivotal trial begun in mid-September is evaluating the electrochemical-based sensor technology for the continuous monitoring of glucose levels. Enrollment in the Phase IV study is scheduled to be complete by Oct. 17. Data analysis will take about six weeks, the company says.
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