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Medical Devices / Submissions and Approvals / Research and Development

Integrity Applications Advances in FDA Approval Process for GlucoTrack

Nov. 2, 2015
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Integrity Applications announced that it has met with the FDA to discuss clinical trial protocol for its GlucoTrack Model DF-F. 

GlucoTrack is a non-invasive device designed for measuring glucose levels of people with Type 2 diabetes or at risk of developing diabetes.

The company submitted pre-submission documents to the FDA in August, including the U.S. clinical trial protocol.

Integrity expects to begin clinical trials in the United States in early 2016. — Michael Cipriano