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In Brief: MiniMed

This article was originally published in The Gray Sheet

Executive Summary

MiniMed: Continuous subcutaneous glucose sensor 510(k) submitted to FDA, the company reports Dec. 17. MiniMed told the UBS Life Sciences conference in October that its 60-patient pivotal trial for the electrochemical-based sensor technology was in final stages and that a 510(k) for a "holter-style" glucose monitor would be submitted by year-end ("The Gray Sheet" Oct. 20, I&W-3). The company says it hopes to develop a series of products from the technology, including a hyper/hypo-glycemic alarm device, a 510(k) for which is expected to be submitted in early 1998...

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