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Approvals and Clearances - Biocontrol Technology:

This article was originally published in Clinica

Executive Summary

The FDA has withdrawn Biocontrol Technology's 510(k) submission for its Diasensor 1000 noninvasive glucose sensor for diabetics to use in their own homes. The FDA has decided that the company has not provided sufficient data for home use, its primary indication. Biocontrol Technology, based in Pittsburgh, Pennsylvania, says that it now planning a study of its device involving diabetic patients using it at home.

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